willdate
CMS recommends coverage for renal denervation for hypertension
The US Centres for Medicare & Medicaid Services (CMS) has issued its proposed National Coverage ...
CE mark approval for Biosensors’ Imperia THV delivery system
Biosensors International has received CE mark certification for the Imperia delivery system under th...
Finerenone approved to treat heart failure patients with low ejection fraction
Bayer has announced that the US Food and Drug Administration (FDA) has approved Kerendia (finere...
US patent issued for algorithm to predict renal denervation response
Geneticure has announced that the US Patent and Trademark Office has granted a patent for a gene...
Germany sees “exponential” growth in tricuspid interventions
Transcatheter therapies for the treatment of tricuspid regurgitation (TR) have grown “exponentially”...
First patient receives CorWave left ventricular assist system
CorWave has announced the first-in-human implantation of its left ventricular assist system (LVAS) b...
CorFlow Therapeutics gains US FDA approval for IDE trial
CorFlow Therapeutics has announced that the US Food & Drug Administration (FDA) has approved...
First patient treated in trial of multi-organ denervation for uncontrolled hypertension
Medtronic has announced that the treatment of the first patient in the SPYRAL GEMINI pilot programme...
VitalFlow ECMO system gains CE mark approval
Medtronic has announced that its VitalFlow extracorporeal membrane oxygenation (ECMO) system has...
EARLY TAVR: Analysis looks at trial’s outcomes based on guideline recommendations
New analysis of the EARLY TAVR trial, in which investigators examined the prevalence of guideline in...
First procedures performed in FRACTURE trial of Bolt IVL system in coronary artery disease
The first US procedures have been performed in the FRACTURE investigational device exemption (ID...
CroíValve secures funding from Horizon Europe EIC Accelerator
CroíValve, developer of the Duo transcatheter system for the treatment of tricuspid regurgitation (T...
New York Valves hears 30-day results of low-profile TAVI valve
Thirty-day results of the US early feasibility study assessing the use of the Siegel (Mirus) 8Fr...
Global study shows widening disparity in mitral valve disease outcomes
Degenerative mitral valve disease has doubled in prevalence globally over the last 30 years, and...
First patient enrolled in EASE HF2 study of Intershunt technology for HFrEF treatment
InterShunt Technologies has announced the start of the EASE HF2 early feasibility study, which is ev...
One-year results show positive safety and haemodynamic performance for biopolymer surgical mitral valve
Foldax has announced the presentation of one-year results from the India clinical trial of the T...
Improved survival seen following TAVI explant compared to redo procedures
Analysis of real-world US data comparing outcomes after post-transcatheter aortic valve implantation...
SEISMIC-HF I study assesses use of non-invasive HFrEF management technology
Cardiosense has announced the publication of results from its SEISMIC-HF I study in the Journal ...
Vivasure Medical submits premarket approval for PerQseal Elite vascular closure device
Vivasure Medical has announced the submission of a premarket approval (PMA) application to the U...
Evoque tricuspid valve replacement system gains Health Canada approval
Edwards Lifesciences has announced that the company’s Evoque tricuspid valve replacement system ...
First patient enrolled in RECOVER-AV trial of AlphaVac F18 system for treatment of acute PE
AngioDynamics has announced the first patient has been enrolled in the RECOVER-AV clinical trial, a ...
Enrolment milestone met in CORCINCH-HF pivotal trial
Ancora Heart has announced that it has reached the first enrolment milestone in the CORCINCH-HF ...
ADA 2025: Semaglutide taken orally shown to reduce cardiovascular risk in type 2 diabetes patients
Research presented at the American Diabetes Association (ADA) 2025 scientific session (20–23 June, C...
Study intensifies call for randomised trial in patients with bicuspid aortic stenosis
The results of a retrospective analysis should act as a “word of caution” against the liberal us...
Stroke rates diverge among TAVI and surgery patients at five years in pragmatic trial
Long-term results of the UK TAVI trial, a pragmatic trial comparing transcatheter aortic valve i...
Ceryx Medical to develop physiologically responsive pacemaker following funding boost
Ceryx Medical has announced the successful closure of a new funding round, bringing the company’s to...
New medical device reporting requirements come into effect in the UK
New regulations have come into effect in the UK which place a greater emphasis on medical device man...
Prevencio granted patents to protect proprietary coronary artery disease blood test platform
Prevencio has been granted patents for its HART CADhs test in the USA—the second US patent for this ...
Enrolment completed in ATHENS-HF first-in-human study of Adona interatrial atrial shunt
Adona Medical has announced the completion of enrolment in the ATHENS-HF first-in-human study, s...
MedHub-AI and Terumo partner to distribute AI-powered FFR system in Japan
MedHub-AI has announced a distribution agreement with Terumo Corporation to bring its AutocathFF...
Funding round allows completion of RESPONDER-HF trial of Corvia atrial shunt
Corvia Medical has announced the successful closure of a US$55 million funding round with funds ...
EMPACT-MI analysis “reassuring” on use of empagliflozin in patients with poor kidney function
Empagliflozin preserved kidney function and was safe to initiate in heart attack patients, findi...
Aventus thrombectomy system gains FDA clearance for PE treatment
Inquis Medical has announced that its Aventus thrombectomy system has received 510(k) clearance from...
TRANSFORM II study of sirolimus DCB completes patient enrolment
Enrolment has been completed in the TRANSFORM II randomised controlled trial, comparing the MagicTou...
EuroPCR 2025: Thirty-day results show promise for Lux-Valve Plus TTVR system
Jenscare has announced the release of 30-day follow-up results of the TRINITY trial of the LuX-V...
Surgical ablation during CABG carries survival advantage for patients with preexisting AF
Medicare patients with atrial fibrillation (AF) who undergo surgical ablation during isolated corona...
Tria polymer mitral valve gains Indian CDSCO approval
Foldax has announced that the Indian Central Drugs Standard Control Organization (CDSCO) has approve...
Trial of DCB and scaffold technologies enrols first CTO-PCI patients
Biotronik has announced the enrolment of the first patient in the Leave Nothing Behind-trial, which ...
Boston Scientific withdraws TAVI devices from the market
Boston Scientific has announced the surprise move to cease sales of its Acurate transcatheter aortic...
EuroPCR 2025: Myval shows promise in latest comparative studies against contemporary TAVI platforms
New data comparing the Myval transcatheter aortic valve implantation (TAVI) system (Meril Life S...
Abbott’s Tendyne TMVR system gains US FDA approval
Abbott has announced US Food and Drug Administration (FDA) approval for its Tendyne transcathete...
Prevail DCB gains expanded CE mark indications
Medtronic has received CE mark approval for several expanded indications for the treatment of corona...
EuroPCR 2025 hears early outcomes of Topaz TTVR system
TRiCares has announced the presentation of data in a late-breaking session at EuroPCR 2025 (20–2...
EuroPCR 2025: DynamX coronary bioadaptor “durable” through three years
Elixir Medical has announced three-year results from the 445-patient BIOADAPTOR 1:1 randomised c...
EuroPCR 2025: Three-year data available for Freesolve resorbable magnesium scaffold
Thirty-six-month follow-up data from the BIOMAG-I first-in-human trial assessing Biotronik’s Freesol...
Medtronic TAVI platforms gain CE mark for expanded redo TAVI indication
Medtronic has announced it has received CE mark for the expanded redo transcatheter aortic valve...
EuroPCR 2025: Sustained reduction in TR seen at two years with Triclip in real-world data
Two-year outcomes from the bRIGHT registry, a prospective multicentre registry detailing real-wo...
Tackling unacceptable mortality in aortic stenosis: A call to expand TAVI access
Transcatheter aortic valve implantation (TAVI) can be a lifesaving intervention for individuals with...
EuroPCR 2025: Search for suitable candidates for cerebral embolic protection continues
A pooled, individual patient-level data meta-analysis of two trials investigating the use of the Sen...
Trial seeks to demonstrate benefit of ultra-low dose X-ray technology
Royal Philips has announced the launch of the RADIQAL trial, a multicentre, randomised study see...
EuroPCR 2025: All-female coronary IVL trial reports positive outcomes at 30 days
Thirty-day primary endpoint results of EMPOWER CAD, the first prospective, real-world percutaneo...
Cordis initiates SELUTION global coronary registry of coronary DCB
Cordis has announced the initiation of the SELUTION global coronary registry, a prospective study en...
Cytokinetics shares topline results from MAPLE-HCM trial
Cytokinetics has announced positive topline results from MAPLE-HCM, a phase 3 clinical trial compari...
FAVOR III identifies major risk factors of cardiovascular events after PCI
New findings from the FAVOR III China trial demonstrate that kidney function, followed by body m...
“Urgent need” to move away from lead in mitigating cath lab radiation exposure
With an increasing focus on the harmful impact of radiation exposure, as well as the risk of ort...
Advertorial: New data underline the importance of lifetime management of aortic stenosis patients
This advertorial is sponsored by Medtronic
As transcatheter aortic valve implantation (TAVI) ...
Mayra Guerrero
Mayra Guerrero (Mayo Clinic, Rochester, USA) speaks to Cardiovascular News about her life and career...
Cardiovascular News – Issue 77 – May 2025
In this issue:
Lancet Commission urges reframing of coronary disease towards atherosclerosis
...
Early analysis of BIOPATTERN trial offers insights on make-up of coronary plaque
PlaqueTec has announced new research findings from interim data analysis of its ongoing BIOPATTERN t...
Heartflow shares two-year data from FISH&CHIPS study
Heartflow has announced two-year data from FISH&CHIPS, a real-world, multicentre, retrospect...
FastWave Medical to commence coronary feasibility study of laser IVL system
FastWave Medical has secured institutional review board (IRB) approval to commence a coronary feasib...
SCAI names Srihari S Naidu as president
The Society for Cardiovascular Angiography & Interventions (SCAI) has announced its new lead...
SCAI 2025: Early TAVI “should be preferred to clinical surveillance in all age groups”
Analysis from the EARLY TAVR trial, presented at the 2025 Society for Cardiovascular Angiography &am...
SCAI 2025: Novel leaflet modification technique shows promise in reducing LVOT obstruction in mitral valve replacement
A novel technique to reduce left ventricular outflow tract (LVOT) obstruction during transcathet...
SCAI 2025: Stenting “improves long-term survival” for patients undergoing CTO PCI
In patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI), stent...
SCAI 2025: SAPT after TAVI should be considered “standard of care”
Single antiplatelet therapy (SAPT) after transcatheter aortic valve implantation (TAVI) is associate...
CX 2025: Managing blood pressure with medical therapy may play a role in limiting AAA growth
Results from the Central blood pressure and variability evaluation in abdominal aortic aneurysm ...
CX 2025: Bioresorbable scaffold technology has ‘potential to be a new paradigm for femoropopliteal endovascular intervention’
In Wednesday's peripheral arterial programme, which hosted several podium-first presentations, lower...
Edwards’ Sapien 3 lands US FDA approval for the treatment of asymptomatic severe AS
Edwards Lifesciences has announced that the US Food and Drug Administration (FDA) has approved i...
Virtue trial to compare sirolimus and paclitaxel DCB technologies
Orchestra BioMed Holdings has announced that the US Food and Drug Administration (FDA) has approved ...
STS launches risk calculator for ascending aorta and aortic root surgery
The Society of Thoracic Surgeons (STS) has announced the launch of its latest surgical risk calculat...
PerQseal Elite vascular closure system gains CE mark
Vivasure Medical has announced European CE mark approval of the PerQseal Elite vascular closure syst...
Atrioventricular interval modulation therapy granted US FDA breakthrough designation
Orchestra BioMed Holdings has announced that the US Food and Drug Administration (FDA) has granted b...
Eight-year data “encouraging” for aortic valves using Resilia tissue technology
Edwards Lifesciences has announced new eight-year data showing that patients receiving aortic surgic...
Terumo brings Medis QFR 3.0 to US market
Terumo Health Outcomes (THO), a division of Terumo Interventional Systems (TIS), has announced that ...
Edward Lifesciences’ Sapien M3 transfemoral mitral valve system gains CE mark
Edwards Lifesciences has announced that the company’s Sapien M3 mitral valve replacement system ...
FFR-guided PCI catches up to CABG at five years in FAME 3 study
Five-year results of the FAME 3 trial, comparing fractional flow reserve (FFR)-guided percutaneo...
First cases performed with AtriClip PRO-Mini LAA exclusion system
AtriCure has announced the first use of the newest AtriClip device for minimally invasive concomitan...
Elixir Medical launches LithiX Hertz Contact IVL system in Europe
Elixir Medical has announced EU medical device regulation (MDR) CE mark approval and commercial laun...
Trial results open door to frozen plasma alternative for bleeding management in cardiac surgery
Four-factor prothrombin complex concentrate (4F-PCC)—a shelf-stable medication containing freeze...
“Sustained” clinical benefits seen at six months in Altavalve early feasibility study
Results of the Altavalve early feasibility study (EFS) evaluating outcomes of the AltaValve (4C ...
HighLife granted US FDA breakthrough designation for TMVR system
HighLife SAS has announced that that the US Food and Drug Administration (FDA) has granted breakthro...
US FDA clears phase 3 clinical study of ASI-02 in patients undergoing TTE
The US Food and Drug Administration (FDA) has cleared Agitated Solutions Incorporated’s (ASI’s) inve...
Shockwave commences trial of Javelin IVL catheter in complex coronary disease
Shockwave Medical, part of Johnson & Johnson MedTech, has initiated its pivotal FORWARD CAD ...
DurAVR transcatheter heart valve reaches 100 patients
Anteris Technologies has announced that the biomimetic DurAVR transcatheter heart valve (THV) ha...
ACC.25: Low-dose colchicine seen to reduce coronary plaque progression in EKSTROM trial
Low-dose colchicine (0.5mg per day) significantly reduced the total plaque volume progression by 1.1...
CONFORM IDE trial reaches enrolment milestone
Conformal Medical has announced the enrolment of its 500th patient in the CONFORM investigationa...
Lancet Commission urges reframing of coronary disease towards atherosclerosis
Experts in the treatment of coronary artery disease have recommended reframing the perception of...
Teleflex announces US FDA clearance for AC3 Range intra-aortic balloon pump
Teleflex has announced US Food and Drug Administration (FDA) 510(k) clearance of the AC3 Range intra...
ACC.25: ECLIPSE study results support routine use of intravascular imaging during PCI of calcified lesions, investigators say
Using intravascular imaging (IVI) to guide drug-eluting stent implantation during complex percut...
ACC.25: TEER with Triclip reduces heart failure hospitalisation versus medical therapy among TR patients in TRILUMINATE trial
Patients undergoing transcatheter edge-to-edge repair (TEER) using the Triclip (Abbott) system f...
ACC.25: Studies evaluate aortic stenosis referral and detection
Edwards Lifesciences has announced new scientific evidence presented during the 2025 American Co...
Early feasibility study of Siegel 8Fr TAVI valve launches
MiRus has announced the launch of the US multicentre early feasibility study (EFS) of the Siegel...
ACC.25: ALIGN-AR reports positive outcomes with dedicated TAVI device for aortic regurgitation
Data from 500 patients treated for aortic regurgitation with the Trilogy (JenaValve) transcathet...
ACC.25: Evolut Low Risk trial shows comparable rates of all-cause mortality and stroke with TAVI and surgery at five years
Latest data from the Evolut Low Risk trial demonstrate a numerically lower rate of all-cause mor...
ACC.25: Cerebral embolic protection found not to reduce stroke in BHF PROTECT TAVI trial
Use of cerebral embolic protection with the Sentinel (Boston Scientific) device during transcath...
ACC.25: Semaglutide improves walk distance for PAD patients with diabetes
Semaglutide significantly improved maximal walking distance in people with symptomatic periphera...
ACC.25: Bentracimab can reverse bleeding complications linked to ticagrelor
An investigational monoclonal antibody called bentracimab can safely and effectively reverse pot...
ACC.25: Rivaroxaban “a viable alternative to warfarin” in STEMI patients with left-ventricular thrombus
At three months of follow-up, patients hospitalised for a serious heart attack who were treated ...
Preliminary IDE trial results demonstrate efficacy of dedicated device for coronary perforations
Teleflex has announced that the preliminary results from its Ringer perfusion balloon catheter (PBC)...
CRT 2025: New TAV-in-SAV data underline importance of aortic valve sizing at index procedure
New data on the outcomes of transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) fol...
New funding to support expansion of clinical programme for Supira Medical pVAD
Supira Medical has announced the successful completion of an oversubscribed series E financing round...
PMcardio STEMI AI ECG tool earns US FDA breakthrough device designation
Powerful Medical has been granted breakthrough device designation by the US Food and Drug Administra...
Abbott to begin TECTONIC trial of IVL therapy prior to coronary stenting
Abbott has announced that the US Food and Drug Administration (FDA) has approved an investigatio...
Cardiac Dimensions secures financing to complete EMPOWER trial
Cardiac Dimensions has closed of a US$53 million series E financing round led by Ally Bridge Gro...
CRT 2025: First-in-human cases using robotic-assisted TMVR system performed in Chile
Details of the successful first-in-human cases of robotic-assisted transcatheter mitral valve re...
GE HealthCare launches AltiX AI.i editions of its Mac-Lab, CardioLab and ComboLab systems
GE HealthCare has announced the launch of the AltiX AI.i edition of its Mac-Lab, CardioLab and Combo...
SMARTFLOW study to assess diagnostic accuracy of AI-powered angiography image interpretation software
AngioInsight has announced the upcoming launch of its pivotal clinical study, SMARTFLOW, to evaluate...
Protembis names four-person advisory board
Protembis has announced establishment of a scientific advisory board (SAB) to provide objective ...
CRT 2025: AGENT IDE trial results “consistent” out to two years using DCB in ISR
Consistent results have been seen out to two years in the AGENT investigational device exemption...
Research project seeks to update cardiovascular risk calculations using latest technology
Robert Wood Johnson University Hospital (RWJUH) and Rutgers Robert Wood Johnson Medical School (...
Laplace Interventional closes series C financing round
Laplace Interventional has completed its series C financing, which will be used to further the c...
Valcare Medical receives US FDA approval to initiate EFS for Amend transseptal system
Valcare Medical has announced the US Food and Drug Administration (FDA) investigational device e...
CRT 2025: Acurate neo2 shows “reassuring” performance in observational study after stuttering IDE trial
Observational data from Sweden’s national registry on coronary and valvular interventions—SWEDEH...
Global Cardiovascular Awards – The full list of winners and highly commended entries
Best Cardiovascular Product Launch – Aurora Extravascular Implantable Cardioverter Defibrillat...
Innovation and excellence celebrated at second Global Cardiovascular Awards
One of interventional cardiology’s master operators, known globally for his landmark work in the fie...
Howard Herrmann appointed CMO for structural heart by Affluent Medical
Affluent Medical has appointed Howard Herrmann (Perelman School of Medicine at the University of...
CRT 2025: ATTENUATE trial shows significant radiation reduction in cath lab procedures using protective drape
A large single-centre randomised trial has shown that the use of a protective scatter radiation ...
CRT 2025: Improved haemodynamics seen with supra-annular TAVI system at two years in SMART trial
Two-year results of the SMART trial, comparing two commonly used transcatheter aortic valve impl...
CRT 2025: SCAAR analysis shows comparable outcomes between Prevail and other DCBs
A real-world study of the Prevail (Medtronic) drug-coated balloon (DCB), comparing the device to...
Josep Rodés-Cabau named as editor-in-chief of Structural Heart
The Cardiovascular Research Foundation (CRF) has announced the appointment of Josep Rodés-Cabau ...
Reflow Medical expands global reach with new European subsidiary
Reflow Medical has announced the opening of its European subsidiary in Landsberg am Lech, Germany. T...
Boston Scientific among investors in latest financing round for 4C Medical Technologies
4C Medical Technologies has closed a US$175 million series D financing round, led by existing shareh...
SCAI highlights cath lab radiation and orthopaedic hazards
A survey conducted by the Society for Cardiovascular Angiography and Interventions (SCAI) highli...
New partnership aims to develop platform for treating heart failure
Boston Scientific, Ajax Health and KKR have collaborated to create FlowMod, a new organisation i...
Cadrenal Therapeutics and Abbott to collaborate on TECH-LVAD trial
Cadrenal Therapeutics has announced the signing of a collaboration agreement with Abbott to supp...
Stereotaxis seeks to broaden use of its robotic magnetic navigation system into multiple endovascular fields
Stereotaxis has announced a US Food and Drug Administration (FDA) regulatory submission for the firs...
DeepQure advances clinical trials of its HyperQure extravascular renal denervation system
DeepQure has announced progress of clinical trials of its extravascular renal denervation device...
Boston Scientific to acquire renal denervation technology developer SoniVie
Boston Scientific has entered into a definitive agreement to acquire SoniVie Ltd, a privately he...
First US commercial cases performed with ShortCut leaflet modification device
Pi-Cardia has announced the first commercial procedures with its ShortCut dedicated leaflet modi...
Pulnovo Medical closes series C financing round in support of two US FDA trials
Pulnovo Medical has announced the closing of nearly US$100 million series C financing.
The round ...
DCB Days examines the new momentum in DCB-PCI
“This technique is here to stay,” says Raban Jeger (Basel, Switzerland) reflecting on the growin...
MyOme launches coronary artery disease polygenic risk assessment tool
MyOme has announced the launch of its coronary artery disease (CAD) polygenic risk modelling (PRS) p...
ACC and AHA acute coronary syndrome guidelines stress radial approach
The American College of Cardiology (ACC) and the American Heart Association (AHA) have released ...
Biotronik partners with Egg Medical to bring radiation protection systems to US healthcare workers
Biotronik is partnering with Egg Medical to co-sell Egg Medical’s EggNest radiation protection syste...
Medtronic commences Prevail Global study as it seeks coronary DCB approvals in USA and Japan
Medtronic has announced that the first patient has been enrolled in its pivotal trial of the Prevail...
First US centres use GE HealthCare’s Flyrcado cardiac PET imaging agent
GE HealthCare has delivered the first patient doses of Flyrcado (flurpiridaz F18) injection, a f...
SCAI offers guidance on alternate access for TAVI
The Society for Cardiovascular Angiography & Interventions (SCAI) has published an expert consen...
Drug therapy may slow progression of aortic valve stenosis
Researchers have demonstrated the potential of a new drug—ataciguat—to significantly slow the pr...
Cardiovascular News – Issue 76 – February 2025: US Edition
In this issue:
World-first cases usher in new era for robotic cardiac surgery
“Myth-busting”...
Cardiovascular News – Issue 76 – February 2025: OUS Edition
In this issue:
World-first cases usher in new era for robotic cardiac surgery
“Myth-busting”...
Advertorial: DCB Days showcases new momentum in drug-coated balloon PCI
This advertorial is sponsored by B Braun Melsungen AG
Drug-coated balloons (DCBs) are building to...
RANGO registry reports long-term safety and efficacy of Angiolite DES
iVascular has announced positive five-year results of the RANGO registry, demonstrating the long-te...
Biotronik’s Freesolve resorbable scaffold to be studied in long lesions
Biotronik has announced the launch of BIOMAG-LL, a pre-market trial focused on confirming the safety...
Bruno Scheller
Despite a complicated early path into medicine, which was shaped by a major tragedy, Bruno Scheller ...
Sotagliflozin “shows new mechanism of action” in reducing heart attack and stroke among diabetics, kidney disease patients
Sotagliflozin, a recently-US Food and Drug Administration (FDA) approved drug for the treatment ...
Challenges of 21st century aortic education, innovation and evidence get top billing at CX 2025
Critical challenges in open and endovascular treatment of aortic disease will be brought into fo...
Economic analysis supports cost-effectiveness of Guardian monitoring system in high-risk acute coronary syndromes
Avertix Medical has announced the publication of new data on the cost-effectiveness of its Guardian ...
THT 2025: eLym system “promising” for treatment of fluid overload in ADHF patients
WhiteSwell has announced positive data from 21 patients treated in the DELTA-HF trial evaluating the...
THT 2025: MODERATO II study demonstrates improved echo markers of diastolic dysfunction through AVIM therapy
Orchestra BioMed has announced a late-breaking presentation of data on the benefits of atriovent...
American Society of Echocardiography releases new guideline on ultrasound-guided vascular access
A new guideline from the American Society of Echocardiography (ASE) aims to provide more detail for ...
THT 2025: Reprieve system meets endpoints in FASTR randomised pilot study
Reprieve Cardiovascular has announced topline results from its FASTR randomised pilot study, evaluat...
Coronary CT angiography-guided management of stable chest pains shows benefit out to 10 years
Coronary computed tomography angiography (CCTA)-guided management of patients with stable chest ...
Heart teams digest role of early aortic intervention following EARLY TAVR and EVOLVED trials
Two trials delivered in late 2024 have offered fresh evidence on the potential role that early inter...
Studies add fuel to debate over choice of surgical or transcatheter strategies in dual treatment of aortic and coronary disease
A large-scale analysis of data from the US Centers for Medicare and Medicaid Services (CMS) inpa...
Data and device tweaks herald ‘practice-changing’ future for bioabsorbable scaffolds
Pending the results of several trials and “iterative changes” to device design, bioabsorbable sc...
First experience of novel transseptal puncture device shared at STS 2025
First-in-human results of a novel transseptal puncture device from Protaryx Medical were present...
Study weighs up discordance between bleeding risk calculation tools
A study assessing the performance of two commonly used definitions for determining which patients ar...
Lifemotion ECMO system receives CE mark certification
CBM Lifemotion has announced Medical Device Regulation (MDR) CE mark certification of its Lifemotion...
Full IDE dataset from AMDS PRESERVE trial presented at STS 2025
Artivion has announced data from the AMDS PERSEVERE clinical trial presented in a late-breaking scie...
EACTS launches grant scheme for heart valve care in underserved regions
A new outreach programme by the European Association for Cardio-Thoracic Surgery (EACTS) has been la...
STS 2025: Analysis sheds light on impact of surgeon preference in choice of multi- versus single-arterial grafting in CABG
In patients undergoing coronary artery bypass grafting (CABG), a novel analysis evaluating surgeon p...
Joseph Sabik elected STS president
The Society of Thoracic Surgeons (STS) has announced the election of Joseph Sabik (Cleveland Medical...
STS 2025: Mechanical aortic valves “confer a significant survival advantage” in patients under 60
Mechanical aortic valve replacement (AVR) provides significant long-term survival benefits for p...
Atraverse announces clinical evidence validating Hotwire radiofrequency guidewire system
Clinical evidence supporting the efficacy, safety and efficiency of Atraverse Medical's Hotwire ...
NFL stars to get HeartFlow analysis through GAMEFILM registry study
HeartFlow has partnered with the Boone Heart Institute (Colorado, USA) to launch the GAMEFILM regist...
First commercial cases using CrossFAST advanced delivery system performed in USA
Vantis Vascular has announced the first commercial use of its CrossFAST integrated microcatheter adv...
Accuryn monitoring system detects kidney injury in cardiac surgery patients “earlier than standard serum creatine criteria”
Research published in the Journal of Cardiothoracic and Vascular Anesthesia, assesses the effect...
Caranx Medical makes US FDA submission for AI TAVI guidance software
Caranx Medical has announced that it has made a submission to the US Food and Drug Admnistration...
Factor XI inhibitor ‘lives up to promise’ of reduced bleeding events in AF patients
Researchers from Mass General Brigham (Boston, USA) have evaluated a drug that represents a new clas...
Humacyte files for investigational use of tissue engineered vessel in CABG
Humacyte has announced that it plans to file an investigational new drug (IND) application with the ...
Pivotal trial of dissolving film oral anticoagulant reaches completion
Taho Pharmaceuticals has announced the completion of the pivotal trial for TAH3311, an anticoagulant...
Advanced Bifurcation Systems secures latest round of funding
Advanced Bifurcation Systems has announced the successful closure of a US$20.8 million simple agreem...
Surgeons claim “world first” robotic artificial heart pump implant
King Faisal Specialist Hospital and Research Centre (KFSHRC) in Riyadh, Saudi Arabia has perform...
Cardiac surgery societies endorse ESC coronary revascularisation recommendations
Four cardiac surgery societies have endorsed recommendations of the European Society of Cardiology’s...
Alleviant Medical secures funding for second pivotal trial of no-implant atrial shunt
Alleviant Medical has announced a US$90 million financing to fund its second pivotal trial.
The A...
CMS launches review of coverage for renal denervation
The Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (...
Biotronik nets short DAPT and calcified lesion indications for Orsiro Mission DES
Biotronik has announced CE mark approval of two new indications for the Orsiro Mission drug-eluting ...
CoreMedic and InnoRa partner to accelerate development of ChordArt mitral repair system
CoreMedic has entered into a strategic partnership with InnoRa to accelerate clinical development of...
APEX-AV trial results of AlphaVac PE system published in JSCAI
AngioDynamics has announced the publication of the results from the Acute Pulmonary Embolism Extract...
AVENTUS trial of thrombectomy system for PE treatment completes enrolment
Inquis Medical has announced completion of patient enrolment in its AVENTUS clinical trial, a pivota...
First patients treated in TRICURE EFS study of Topaz tricuspid heart valve replacement system
TRiCares has announced that the first patients have been successfully implanted with Topaz, its ...
Relief Cardiovascular closes financing round to fund first-in-human study
Relief Cardiovascular has announced the closing of a US$12 million series A financing.
The fundin...
Boston Scientific to acquire IVL developer Bolt Medical
Boston Scientific has announced it has entered into a definitive agreement to acquire Bolt Medic...
Study finds adverse outcomes after decreased use of paclitaxel-coated devices
A recent analysis of over 270,000 Medicare fee-for-service beneficiaries has found an increase i...
Simpson Interventions announces US FDA regulatory milestones
Simpson Interventions has announced that the Acolyte image-guided crossing and re-entry catheter sys...
Alleviant Medical to commence pivotal trial of no-implant atrial shunt in HFrEF patients
Alleviant Medical has announced two milestones from the US Food and Drug Administration (FDA) relati...
Harmony transcatheter pulmonary valve gains CE mark
Medtronic has received CE mark for the Harmony transcatheter pulmonary valve (TPV) system, a minimal...
RevoEdge high-pressure coronary cutting balloon gains CE mark
BrosMed Medical has obtained CE mark for the RevoEdge high-pressure coronary cutting balloon under t...
Enrolment completed in ALL-RISE trial of FFRangio coronary physiology assessment
CathWorks has announced the successful completion of enrolment of the Advancing Cath Lab Results...
Cardiovascular News’ most-read stories of 2024
Which stories, features and interviews captured the attention of the cardiovascular community across...
First-in-human results “demonstrate potential of Reprieve system” in ADHF treatment
Reprieve Cardiovascular has announced the first-in-human results of the Reprieve System at the CSI F...
First phase of BiVACOR early feasibility study completed
BiVACOR has announced the successful completion of the first phase of the US Food and Drug Administr...
First patients enrolled in JENA-VAD registry
JenaValve Technology has announced the completion of the first patient procedure for inclusion in th...
Impella heart pump approved for use in paediatric patients
The US Food and Drug Administration (FDA) has expanded the indications for the Impella 5.5 with Smar...
Vantis Vascular completes series B financing round
Vantis Vascular has announced the successful closing of US$10 million series B-1 preferred financing...
Developer of robotic heart valve system closes financing round
Capstan Medical has announced the successful closing of an oversubscribed US$110 million Series C, w...
Initial shortlist for Global Cardiovascular Awards revealed
The initial shortlist for the second Global Cardiovascular Awards—which will recognise the important...
First-in-human study of Protaryx transseptal puncture technology completed
Protaryx Medical has announced the completion of its first-in-human (FIH) study, assessing its advan...
Robotic aortic valve replacement offers an “exciting new chapter” in the treatment of aortic valve disease
The rapid growth of transcatheter aortic valve implantation (TAVI) has been the story of the last tw...
Terumo and Medis partner on coronary imaging technology
Terumo Health Outcomes (THO) and Medis Medical Imaging have entered into a strategic partnership in ...
PCR London Valves 2024: Live cases at cardiology conferences “do not compromise patient safety”
Live cases broadcast at interventional cardiology meetings are performed without compromising th...
PERIGON trial demonstrates durability of Avalus aortic valve at seven years
Seven-year results of the PERIGON pivotal trial, assessing the clinical and haemodynamic perform...
TCT 2024 hears early experience with high-definition IVUS system
Details of early studies using a dual-frequency intravascular ultrasound (IVUS) imaging system w...
PCR London Valves 2024: New data presented alongside launch of latest-generation Myval device
New analysis of the Myval transcatheter aortic valve implantation (TAVI) system (Meril Life Scie...
FastWave issued sixth utility patent for its IVL portfolio
FastWave Medical has announced the issuance of its sixth utility patent by the US Patent and Tra...
WVU team performs pioneering combined robotic aortic valve replacement and coronary bypass procedure
The multidisciplinary team at WVU Medicine’s WVU Heart and Vascular Institute (Morgantown, USA) ...
PCR London Valves 2024: Medtronic shares Evolut cusp overlap and PVL data
Medtronic has announced new data for the Evolut transcatheter aortic valve implantation (TAVI) s...
Heart Valve Voice marks 10-year milestone
The UK charity for patients with heart valve disease, Heart Valve Voice, has marked its 10th anniver...
Scottish centres adopt on-screen system for endoscopic vessel harvesting
A Glasgow-based company has announced that three out of four cardiac centres in Scotland are now usi...
Abbott launches its largest Navitor Vision valve size in UK
Abbott has introduced a 35mm sized version of its Navitor Vision transcatheter aortic valve impl...
Health Canada approves Wegovy for non-fatal MI reduction
Novo Nordisk announced today that Wegovy is now approved to reduce the risk of non-fatal myocard...
ACURATE IDE results put spotlight on impact of valve under-expansion after TAVI
“Disappointed is an understatement,” Michael Reardon (Houston Methodist DeBakey Heart & Vasc...
First patient procedures performed with Abbott’s balloon-expandable TAVI system
Abbott has announced the first patient procedures with its investigational transcatheter aortic ...
PCR London Valves 2024: One-year data affirm clinical performance of Sapien 3 Ultra Resilia TAVI system
One-year data highlighting the performance of the Sapien 3 Ultra Resilia (Edwards Lifesciences) ...
Attention turns to multi-organ denervation as new evidence supports “durability” of blood pressure reductions
New research will investigate the safety and efficacy of multi-organ, hepatic artery and renal a...
EACTS past president puts innovation and inclusivity at the top of the agenda
The immediate past president of the European Association for Cardio-Thoracic Surgery (EACTS) spe...
CAPTURE-1 study of EmStop embolic protection system concludes
EmStop has announced the completion of the CAPTURE-1 early feasibility clinical trial assessing the ...
First patients enrolled in high-risk PCI study of Supira pVAD
Supira Medical has announced the initiation and successful patient enrolment in the company's US ear...
AHA 2024: Five-year Amulet IDE data show similar outcomes with Amplatzer and Watchman devices
Latest data from the Amulet investigational device exemption (IDE) trial, comparing the Amplatze...
First patient enrolled in trial of Cysoni temporary pacing technology
Ceryx Medical has announced that the first patient has been enrolled in the RSA-Pace multicentre stu...
ALERT study to use AI to identify underserved patients eligible for TAVI
Medtronic has announced the launch of a randomised study—ALERT—aiming to address the undertreatm...
Second Heart Assist announces further high-risk PCI cases using Whisper mechanical circulatory support device
Second Heart Assist has announced the successful conclusion of its second set of case studies to...
AHA 2024: OPTION trial reports positive outcomes for Watchman FLX at three years after AF ablation
Three-year results from the OPTION clinical trial, comparing the Watchman FLX (Boston Scientific...
AHA 2024: Edoxaban an “effective alternative” to warfarin following valve replacement surgery
Edoxaban may be an effective alternative to warfarin—the current standard of care—for patients under...
AHA 2024: Spironolactone misses primary endpoints in CLEAR SYNERGY trial
Routine use of the blood pressure medication spironolactone among patients who have undergone pe...
Rafael Sádaba
Hailing from Pamplona, northern Spain, cardiac surgeon Rafael Sádaba was born and raised in a medica...
Advertorial: Newest-generation TAVI platforms designed to meet the demands of the modern cath lab
This advertorial is sponsored by Medtronic
As transcatheter aortic valve implantation (TAVI) ...
Cardiovascular News – Issue 75 – November 2024: OUS Edition
In this issue:
Early intervention for aortic stenosis: Trials shed new light on timing for aort...
Cardiovascular News – Issue 75 – November 2024: US Edition
In this issue:
Early intervention for aortic stenosis: Trials shed new light on timing for aort...
BrightHeart gains US FDA clearance for AI ultrasound software for detecting congenital heart defects
BrightHeart has received US Food and Drug (FDA) 510(k) clearance for its first artificial intelligen...
What they don’t teach in fellowship: Business insights for young cardiologists
Interventional cardiologist Amir Kaki (Heart & Vascular Institute, Detroit, USA) shares insi...
Early valve replacement falls short in EVOLVED trial
The question of early intervention among patients with severe aortic stenosis but no symptoms st...
Orbital atherectomy fails to eclipse balloon angioplasty in randomised trial in severely calcified lesions
The routine use of orbital atherectomy prior to percutaneous coronary intervention (PCI) in seve...
Trilogy valve shows favourable results at two years in aortic regurgitation patients
Latest data from the ALIGN AR trial, investigating the use of the Trilogy (JenaValve) transcathe...
CONFIRM-2 registry demonstrates use of AI-enabled quantitative CT for predicting MACE
Late-breaking study results were presented at the TCT 2024 conference as part of the CONFIRM-2 g...
Initial results of Sikelia transcatheter heart valve shared at TCT 2024
MitrAssist Lifesciences has announced initial clinical results of its Sikelia transcatheter heart va...
CABG shows benefit over PCI in patients with diabetes and multivessel disease in Swedish registry study
Coronary artery bypass graft (CABG) surgery is associated with significantly lower all-cause and...
Shockwave Javelin peripheral IVL catheter meets prespecified efficacy and safety performance goals in feasibility and IDE studies
Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first clinical outco...
Two-year LIFE-BTK data show sustained benefits of drug-eluting resorbable scaffold for below-the-knee arteries
Presented today, late-breaking data from the second year of the LIFE-BTK clinical trial demonstr...
US FDA approves IDE application for Katana thrombectomy system
The US Food and Drug Administration (FDA) has approved Akura Medical’s investigational device exempt...
First patient enrolled in study of integrated laser atherectomy and IVL catheter
Royal Philips has announced enrolment of the first patient in the US THOR IDE clinical trial, which ...
TCT 2024 hears one-year results of TRAVEL II study of transcatheter tricuspid replacement system
One-year outcomes of the TRAVEL II study, evaluating the Lux-Valve Plus (Jenscare Scientific) tr...
TCT 2024: Six-month data reflect safety and efficacy of Lithix HC-IVL system
Six-month data from the PINNACLE I study evaluating the safety and performance of the LithiX Her...
TCT 2024: TRISCEND II reports positive outcomes for tricuspid replacement system
The Evoque (Edwards Lifesciences) tricuspid valve replacement system demonstrated superiority co...
TCT 2024: New analysis shows difference in rates of stroke among US and non-US cohorts of PROTECTED TAVR trial
New analysis of the PROTECTED TAVR trial has shown a reduction in stroke within the US portion o...
TCT 2024: Two-year SPYRAL HTN-ON MED show “consistent” effect of renal denervation
Medtronic has announced new, long-term data from the SPYRAL HTN-ON MED clinical trial that showe...
TCT 2024: New evidence could prompt rethink over use of colchicine following acute MI
The largest trial to date to study the impact of colchicine—an anti-inflammatory medicine common...
TCT 2024: PATCH study reports initial positive results for sutureless vascular closure system
Vivasure Medical has announced initial positive results from its US IDE PATCH pivotal study eval...
TCT 2024: Non-invasive ultrasound therapy device shows promise in calcific aortic stenosis
The Valvosoft non-invasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic ...
TCT 2024: Coronary bioadaptor shows clinical benefit in complex PCI sub-groups
Late-breaking data from the INFINITY SWEDEHEART trial demonstrate significant benefit of the Dyn...
TCT 2024: EARLY TAVR shows early intervention may be fruitful in asymptomatic aortic stenosis
EARLY TAVR lived up to its billing as one of the most hotly anticipated trials to be presented a...
EMPOWER CAD all-female IVL trial completes enrolment
Shockwave Medical has announced the completion of enrolment in EMPOWER CAD, the first prospective al...
TCT 2024: TAVI does not shift the dial in heart failure patients with moderate aortic stenosis
Transcatheter aortic valve implantation (TAVI) was no better than a conservative, surveillance s...
TCT 2024: Adjustable valve replacement system wins Shark Tank innovation prize
Symbiosis, the developer of an adjustable transcatheter mitral valve replacement (TMVR) system—V...
Adona interatrial shunt used in first human cases
Adona Medical has announced the successful first-in-human use of its novel interatrial shunt in ...
TCT 2024: Seven-year registry data confirm use of AI-enabled FFRCT
HeartFlow has announced seven-year data confirming the use of its AI-enabled fractional flow res...
First US cases performed with Vertex PE system in SPIRARE II pivotal study
Jupiter Endovascular has announced that the first US patient has been treated in the SPIRARE II US p...
First-in-human results for dual-drug therapy DCB released
Advanced NanoTherapies has announced positive results from its first-in-human (FIH) trial evalua...
Medtronic receives US FDA approval of Affera mapping and ablation system and Sphere-9 catheter
Medtronic has announced US Food and Drug Administration (FDA) approval of the Affera mapping and...
First patients treated with Duo tricuspid coaptation system in TANDEM II study
CroíValve has announced the first patient treated with the Duo system as part of the TANDEM II early...
NICE recommends use of HeartLogic heart failure diagnostic
Boston Scientific has announced that the National Institute for Health and Care Excellence (NICE), h...
Medtronic’s Evolut FX+ TAVI system gains CE mark
Medtronic has received CE mark for the Evolut FX+ transcatheter aortic valve implantation (TAVI)...
First-in-human implants with Luna TMVR system completed
Tioga Cardiovascular, a Shifamed portfolio company, has announced the first-in-human transseptal...
Medtronic’s Prevail DCB to be studied in US IDE trial
Medtronic has received approval of a US Food and Drug Administration (FDA) investigational device ex...
Gentuity HF-OCT imaging system receives FDA clearance
Gentuity has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance f...
COVID-19 infection may increase risk of heart attack up to three years later
An analysis of data in the UK Biobank has found that COVID-19 infection may increase the risk of hea...
Study highlights mortality disparity among minority patients undergoing CABG
Black patients are 22% more likely than white patients to die in the hospital after coronary artery ...
EACTS 2024: Robotic aortic valve replacement shows promise as an alternative to TAVI
Robotic aortic valve replacement (RAVR) may offer an alternative to transcatheter aortic valve i...
MedTech Innovation Forum returns at TCT 2024
Pressing issues in medtech innovation will be on the agenda on the opening day of the 2024 Trans...
Kaminari Medical closes €3.8 million financing round to advance intravascular imaging system
Kaminari Medical has closed a €3.8 million funding round with proceeds to be directed to product...
Ian Meredith joins board of directors at Transverse Medical
Transverse Medical has announced the appointment of Ian T Meredith to the board of directors.
...
EACTS 2024: Digital “prehabilitation” programme reduces adverse events after cardiac surgery
Patients awaiting cardiac surgery who underwent a digital “prehabilitation” programme benefited ...
J&J completes acquisition of V-Wave
Johnson & Johnson has announced the completion of its acquisition of V-Wave, a developer of ...
AI-based aortic stenosis screening software gains US FDA breakthrough designation
AccurKardia has announced that its aortic valve stenosis electrocardiogram (ECG)-based artificial in...
Pivotal trial of AltaValve TMVR system commences in USA and Europe
4C Medical Technologies has commenced enrolment in the ATLAS trial in Europe and USA, a pivotal tria...
FASTR trial of Reprieve system completes enrolment
Reprieve Cardiovascular has announced the completion of enrolment in the FASTR trial, comparing the ...
ESC 2024: Chronic coronary syndrome guidelines clarify role of revascularisation and strengthen imaging recommendations
The European Society of Cardiology (ESC) has issued updated guidelines on the management of chronic ...
Randomised trial results support pausing anticoagulation prior to TAVI
Patients undergoing transcatheter aortic valve implantation (TAVI) do not benefit from the conti...
AtriCure’s launches EnCompass clamp in Europe
AtriCure has received regulatory approval to sell the EnCompass clamp in CE-marked countries in the ...
GLACE study to assess ICE imaging during LAA closure
Conformal Medical has announced the initiation of the GLACE Study, assessing the use of intracar...
US FDA clears Elucid’s PlaqueIQ imaging analysis software
Elucid has received 510(k) clearance from the US Food and Drug Administration (FDA) for its PlaqueIQ...
Advertorial: Stent overexpansion is key to overcoming variable diameter in complex PCI cases
This advertorial is sponsored by iVascular
In certain complex percutaneous coronary intervention ...
HFSA 2024: Aficamten shows improvement in clinical markers used to inform HCM care
Cytokinetics has announced that additional analyses synthesizing data from SEQUOIA-HCM, the pivotal ...
HFSA 2024: One-year data from PROACTIVE-HF show reduction in heart failure hospitalisation and all-cause mortality
Endotronix has announced the one-year clinical results from PROACTIVE-HF, evaluating outcomes fo...
Three-year data from ASSURED study of Cardioform ASD occluder released
Gore has announced the release of three-year data from the ASSURED clinical study, evaluating th...
Renal denervation gains class IIb recommendation in ESC guidelines
Latest guidelines from the European Society of Cardiology (ESC) on the management of blood press...
ShortCut leaflet splitting device gains US FDA market clearance
The US Food and Drug Administration (FDA) has provided market clearance for the ShortCut (Pi-Car...
US FDA approves Flyrcado injection PET radiotracer for diagnosis of coronary artery disease
GE HealthCare has announced that the US Food and Drug Administration (FDA) has granted approval of F...
Medtronic launches VitalFlow ECMO system
Medtronic has announced the launch of a new extracorporeal membrane oxygenation (ECMO) system—Vi...
Meta-analysis supports DAPT de-escalation after PCI
De-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of...
UK societies call for concerted effort to tackle cardiovascular disease in women
Concerted efforts are needed to address unmet needs and ensure parity of care for women with car...
SSCORE registry of super saturated oxygen therapy in LAD STEMI patients begins
Zoll has announced that the first patient has been enrolled in the SSCORE registry, a prospective st...
Latest TRILUMINATE and TRI.Fr data add to growing body of evidence for tricuspid TEER
Data continue to emerge supporting the safety and efficacy of transcatheter-edge-to-edge repair ...
First Topaz tricuspid valve implanted in European pivotal study
TRiCares SAS has announced the first implantation of its Topaz transfemoral tricuspid heart valve re...
TEER non-inferior to surgery in MATTERHORN trial but dividing lines remain
Investigators of a trial comparing transcatheter edge-to-edge repair (TEER) with surgery in pati...
First cases completed in SPIRARE I trial with Vertex system
Jupiter Endovascular has announced that the first two patients have been treated in SPIRARE I, a...
AI powered structural heart planning software gains US FDA clearance
Dasi Simulations has announced that its second product—Dasi Dimensions—has earned US Food and Drug A...
PlaqueTec and RxCelerate collaborate on early phase drug discovery for coronary artery disease
PlaqueTec and RxCelerate have announced the successful completion of a collaboration to assess small...
Novostia announces new funding and leadership changes
Novostia has announced a leadership transition alongside the successful completion of a CHF 5.6 mill...
No-touch graft harvesting technique shows “no benefit, but significant harm” in SWEDEGRAFT study
A multicentre, registry-based, randomised trial of the ‘no-touch’ technique for graft harvesting...
SpectraWAVE eyes commercial expansion of its HypreVUE intravascular imaging system
SpectraWAVE has announced a US$50M series B funding round which the company says will advance co...
Advertorial: DCB may be an appealing strategy in diabetic patients undergoing PCI
This advertorial is sponsored by B Braun Melsungen AG
Diabetic patients with coronary artery ...
CorFlow completes series B funding round to evaluate therapeutic treatments for MVO using CoFl system
CorFlow Therapeutics AG (CorFlow) announced today that it has raised €44 million in series B fun...
Brightflow SAS raises €16.5M in series A financing round
Brightflow SAS has announces the successful completion of an oversubscribed €16.5M ($18M) in equ...
AI-powered point-of-care ultrasound system gains US FDA approval
AISAP, a medical technology company developing AI-powered point-of-care assisted diagnosis (POCA...
First two TAVI procedures completed using Venus-Vitae valve in SMART ALIGN trial
Venus Medtech has announced that its next-generation balloon-expandable dry-tissue transcatheter...
ESC 2024: Coronary bioadaptor non-inferior to DES at one-year for TLF
The DynamX (Elixir Medical) bioadaptor system met non-inferiority at one year for target lesion fail...
ESC 2024: New evidence suggests fasting not needed before cardiac catheterisation procedures
A randomised trial testing whether the removal of fasting requirements prior to cath lab procedures ...
ESC 2024: Invasive strategy does not reduce risk of cardiovascular death or non-fatal MI in older NSTEMI patients
A trial comparing an invasive and a conservative strategy to treat patients over the age of 75 years...
ESC 2024: TAVI “superior” to surgery in women with severe aortic stenosis
The first trial comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve re...
ESC 2024: “No need” for potassium supplementation after CABG
Supplementing potassium for patients who have undergone coronary artery bypass graft (CABG) surg...
ESC 2024: RESHAPE-HF2 results move conversation forward on effectiveness of TEER in functional MR
A strategy of mitral transcatheter edge-to-edge repair (TEER) plus medical therapy in patients with ...
ESC hypertension guidelines stipulate conditions for renal denervation use
ESC guidelines on the management of elevated blood pressure and hypertension include recommendations...
Will the NHS broaden its commissioning criteria for TEER?
Jonathan Byrne, consultant cardiologist at King's College Hospital (London, UK) and UK lead of t...
ESC 2024: Remote echocardiograms offer “relatively good diagnostic accuracy”
Research presented at the 2024 European Society of Cardiology (ESC) congress (30 August–2 Septem...
First patient treated with AtriClip FLEX-Mini LAA device
AtriCure has announced that the first patient has been treated with the AtriClip FLEX-Mini left atri...
Acurate Prime TAVI system gains CE mark
Boston Scientific has obtained CE mark for the Acurate Prime aortic valve system, the newest tra...
ESC 2024: AI virtual voice assistant identifies complications after TAVI
Clinical follow-up using virtual voice technology helped identify complications after transcathe...
Brightflow appoints Sophie Humbert as CEO
Brightflow SAS has announced the appointment of Sophie Humbert as chief executive officer (CEO).
...
AtriClip LAA device receives expanded indication
AtriCure has received an expanded indication for the AtriClip left atrial appendage (LAA) exclusion ...
AI-based point-of-care ultrasound software gets US FDA clearance
AISAP has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for ...
Nanox receives FDA approval for its latest generation AI platform for coronary disease detection
Nano X Imaging has announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, ...
Cardiovascular News – Issue 74 – September 2024: US Edition
In this issue:
Is it time for rethinking major adverse cardiovascular events (MACE) as an endpo...
Cardiovascular News – Issue 74 – September 2024: OUS Edition
In this issue:
Is it time for rethinking major adverse cardiovascular events (MACE) as an endpo...
Labelling change allows removal of aspirin following HeartMate 3 implant
Abbott has announced that the US Food and Drug Administration (FDA) has approved a change to its...
Rasha Al-Lamee
Best known for her work as the principal investigator in the ORBITA trial—a placebo-controlled tri...
Johnson & Johnson to acquire V-Wave
Johnson & Johnson has entered into a definitive agreement to acquire V-Wave, a privately-hel...
AVS and Jacobs Institute partner on study of Pulse IVL system
Amplitude Vascular Systems (AVS), developer of the Pulse intravascular lithotripsy (IVL) platform an...
Jupiter Endovascular secures multimillion dollar financing round
Jupiter Endovascular has exited stealth mode with a US$21 million round of financing, with the fundi...
Genesis MedTech announces sale of JC Medical to Edwards Lifesciences
Genesis MedTech has sold JC Medical to Edwards Lifesciences, in a deal that includes the intellectua...
Medical advisory board appointed to lead innovation at Radiaction
Radiaction Medical has announced the formation of its US medical advisory board.
The advisory boa...
Survey highlights complication rates among pregnant cardiology trainees
A survey among female cardiology fellows has shown a higher rate of obstetrical complications among ...
AI models have potential in heart team decision-making, but beware blindspots
Large language models such as ChatGPT and Google Bard could assist heart teams in decision makin...
BioCardia submits 510(k) approval for Morph DNA steerable introducer sheath family
BioCardia has submitted a 510(k) for approval of its patented Morph DNA steerable introducer sheath ...
NMPA approves SyMap renal denervation system for treatment of uncontrolled hypertension
China’s National Medical Products Administration (NMPA) has granted a Class III Medical Devices Cert...
Funding allows CroíValve to advance US early feasibility study of Duo tricuspid valve
CroíValve has closed a US$16 million Series B financing round. Proceeds from the financing will be u...
Trialists call for rethink over use of MACE as a primary endpoint in cardiovascular trials
Three noted cardiovascular trialists have called for a reappraisal of major adverse cardiovascul...
Ringer perfusion balloon catheter gains US FDA approval
Teleflex has announced US Food and Drug Administration (FDA) 510(k) clearance of the Ringer perfusio...
Research aims to understand training needs for left-handed cardiac surgeons
For the estimated one in 10 left handers in the general population many day-to-day activities requir...
EU bank finances maker of ProtEmbo cerebral embolic protection system
The European Investment Bank (EIB)—the investment arm of the European Union (EU)—is providing €20 mi...
SavvyWire pre-shaped pressure guidewire gains CE mark
Haemonetics Corporation has announced CE mark certification and the first commercial European proced...
Bavaria joins board of directors at PECA Labs
PECA Labs has added Joseph E Bavaria (Jefferson Health and Sidney Kimmel Medical College, Philad...
Diabetic PCI patients have a higher risk of stent failure without glycaemic control
An observational study of patients with type 2 diabetes treated for coronary artery disease with...
Texas Heart Institute performs first-in-human implantation of BiVACOR total artificial heart
The Texas Heart Institute and BiVACOR, a clinical-stage medical device company, announced today ...
AMEND TS EU pilot study of mitral valve repair device expands to Italy
Valcare Medical has announced the expansion of the AMEND TS EU pilot study to Italy.
The Ital...
First patients treated in US GPS study of Paradise renal denervation system
The first patients in the USA have been treated in Recor Medical’s Global Paradise System US Pos...
Abbott’s Navitor Vision TAVI valve rolled out in UK and Ireland
Abbott is rolling out the latest iteration of its Navitor transcatheter aortic valve implantatio...
Edwards Lifesciences continues acquisition spree, announcing JenaValve and Endotronix deals
Edwards Lifesciences has announced further expansion of its structural heart portfolio, after enteri...
Prevencio receives US patent for AI-powered test of obstructive coronary artery disease
Prevencio has been issued a patent from the United States Patent and Trademark Office for its blood ...
Latest round of funding secured to boost clinical programmes for Topaz tricuspid valve system
TRiCares SAS has announced it has raised US$50 million (€46 million) in a Series D financing rou...
Funding secured to support clinical study of Elevate heart pump
Magenta Medical, developer of the Elevate heart pump, has closed a US$105 million financing roun...
AtriClip LAA exclusion system granted approval for marketing in China
AtriCure has received regulatory approval from the National Medical Products Administration (NMPA) o...
RSA-pace study of Cysoni-XT temporary pacing system granted approval
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ceryx Medical’s clini...
Royal Brompton Hospital installs UK’s first Magnetom Cima.X MRI system
Royal Brompton Hospital, part of Guy’s and St Thomas’ NHS Foundation Trust (London, UK) has beco...
ContraBand pulmonary artery banding system gains US FDA breakthrough status for HFrEF treatment
Restore Medical has been granted breakthrough device designation by the US Food and Drug Administrat...
Elucid begins site recruitment for PRE-VUE CT study
Elucid has initiated site recruitment for its PRE-VUE CT registry study.
The study is an internat...
Materialise announces FEops acquisition to offer “interactive” planning for structural heart procedures
Materialise, a provider of 3D printing software and services, has acquired FEops, a Belgian comp...
New publication highlights performance of iVascular’s Essential pro DCB
iVascular has announced the publication of results from a prospective single-centre study, demon...
Consumer wearables found to have clinical value in assessing treatment for AF and heart failure
Monitoring of heart rate and physical activity using consumer wearable devices was found to have cli...
First US heart failure patient receives V-LAP left atrial pressure sensor
A patient in Cincinnati has become the first in the USA to receive a system that enables remote ...
Edwards Lifesciences to acquire TMVR developer Innovalve
Edwards Lifesciences has announced it has exercised its option to acquire Innovalve Bio Medical, an ...
Health Canada grants approval for use of Pascal Precision to reduce significant, symptomatic MR
Edwards Lifesciences has announced Health Canada’s approval of the company's Pascal Precision transc...
Global Cardiovascular Awards return in 2025
Entries have opened for the second edition of the Global Cardiovascular Awards, celebrating innovati...
TruLeaf Medical to commence clinical trial of RoseDoc two-stage TMVR system
TruLeaf Medical has received Helsinki Ethics Committee approval in Uzbekistan to conduct a clini...
New research highlights sex disparity in treatment of CABG patients
Women over the age of 65 who require coronary artery bypass graft (CABG) surgery are more likely...
MANIFEST-17k registry shows promising safety performance for PFA
Pulsed field ablation (PFA) is safe for treating patients with common types of atrial fibrillati...
Adona Medical secures financing to initiate clinical use of interatrial shunt device
Adona Medical has secured US$33.5 million in Series C financing, with the money to be used to fu...
Financing secured to develop “personalised” tricuspid repair system
StarTric has finalised a new seed financing round to advance its next-generation technology for the ...
Medtech Insights: Trial pipeline underpins growth strategy for Watchman LAAC device
Investment in a programme of clinical trials will underpin Boston Scientific’s strategy to expand th...
Orsiro Mission DES available in expanded maximum allowed diameters range
Biotronik has announced the availability of an expanded maximum allowed diameters (MAD) range for th...
Anteris Technologies and v2vmedtech reach concept lock on VClip TEER system
Anteris Technologies and v2vmedtech, a structural heart company developing a next-generation transca...
DEEPER CORONARY trial of Spur system for coronary in-stent restenosis gets underway
Reflow Medical has announced the first patient enrolments in DEEPER CORONARY, a pilot study of its d...
First patients enrolled in study of pulmonary artery denervation treatment
Pulnovo Medical Limited has announced the successful initiation and first two-patient enrolment for ...
Valcare Medical appoints scientific advisory board to guide development of mitral annuloplasty device
Valcare Medical has announced the formation of a scientific advisory board (SAB) to provide insi...
CardioFlow’s second-generation TAVI system gains CE-MDR certification
MicroPort CardioFlow Medtech Corporation has announced that its self-developed second-generation tra...
FASTIII trial of angiography-based vessel fractional flow reserve completes enrolment
Pie Medical Imaging has announced the completion of enrolment in FASTIII, a multicentre randomised c...
DynamX sirolimus-eluting bioadaptor system gains US FDA breakthrough designation
Elixir Medical has announced that its novel bioadaptive implant, the DynamX sirolimus-eluting co...
Cardiac-MRI data from DurAVR FIH study shared at New York Valves
Cardiac magnetic resonance imaging (MRI) data from the first-in-human study of the DurAVR transc...
Six-month TANDEM I results “promising” for Duo tricuspid coaptation system
Six-month results from the TANDEM I first-in-human clinical trial, investigating the CroíValve D...
DeepQure receives IDE approval of extravascular renal denervation system to treat resistant hypertension
DeepQure, a Seoul based medical device company with a novel, extravascular solution for renal de...
Biopolymer surgical mitral valve sees favourable results at 30 days
Thirty-day results from the Indian clinical study of the Foldax Tria surgical mitral valve in pa...
Abbott receives CE mark for Aveir dual chamber leadless pacemaker system
Abbott has received CE mark in Europe for the Aveir dual chamber (DR) leadless pacemaker system.
...
First-in-human results with Mirus Siegel TAVI valve presented at New York Valves 2024
Initial experience with the Siegel (Mirus) 8Fr transcatheter aortic valve implantation (TAVI) de...
Investigators find small reduction in disabling stroke from embolic protection device use
Analysis of data from the TVT registry, looking at the impact of cerebral embolic protection dev...
New York Valves hears five-year data from PARTNER trials focused on small annulus patients
Results of an analysis of data from the PARTNER trials examining outcomes of transcatheter aorti...
Edwards Lifesciences to strengthen structural heart business after sale of Critical Care group
Edwards Lifesciences has announced that it has entered into a definitive agreement to sell its Criti...
HighLife to initiate US pivotal study of transseptal mitral valve replacement system
HighLife SAS has announced that the US Food and Drug Administration (FDA) has granted an investigati...
First patients treated in pilot study of Half Moon TMVR device
Half Moon Medical has announced the treatment of 15 patients with its second generation Half Moo...
First transseptal TMVR with Saturn valve performed in CASSINI-EU study
InnovHeart has announced the first transseptal clinical trial implant with the proprietary Saturn tr...
Terumo Cardiovascular gains US FDA clearance for CDI OneView monitoring system
Terumo Cardiovascular has announced that the US Food and Drug Administration (FDA) has granted 5...
Valentin Fuster given WHF Lifetime Achievement Award
Valentin Fuster, president of Mount Sinai Heart and physician-in-chief of the Mount Sinai Hospit...
US FDA gives breakthrough device designation for lipoprotein blood test
Roche has announced that the Tina-quant lipoprotein Lp(a) RxDx assay has received breakthrough devic...
EuroPCR 2024: Coronary implant with “site-specific” antithrombotic delivery shows promise at one year
Twelve-month outcomes from the DESyne BDS Plus trial, evaluating a novel triple drug-eluting cor...
First patients enrolled in AMEND TS pilot study
Valcare Medical has announced the successful completion of the first two enrolments in the AMEND TS ...
EuroPCR 2024: Leaflet splitting device may offer efficient option for avoiding coronary obstruction during valve-in-valve procedures
Insights from the investigational device exemption (IDE) pivotal study of the Shortcut (Pi-Cardia) l...
GE Healthcare and Medis Medical collaborate to commercialise QFR technology
GE HealthCare and Medis Medical Imaging have announced a collaboration that they say is aimed at...
EuroPCR 2024: Coronary bioadaptor system shows sustained reduction of TLF at two years in BIOADAPTOR RCT
Two-year results from the BIOADAPTOR 1:1 randomised controlled trial (RCT), comparing the DynamX...
Anteris Technologies reports successful deployment of DurAVR in challenging valve-in-valve case
Anteris Technologies has announced the successful completion of a case involving a patient receiving...
EuroPCR 2024: SMART trial data offer new insight on TAVI device choice in women
Data from the SMART trial—in which it was shown that a self-expanding transcatheter aortic valve...
EuroPCR 2024: TAVI device with intermediate sizing shown to be non-inferior to contemporary platforms in LANDMARK trial
Early outcomes following the use of a novel balloon-expandable transcatheter aortic valve implan...
EuroPCR 2024: NOTION-2 one-year results prompt questions over TAVI in young, low-risk patients with bicuspid aortic valves
Analysis of one-year results from the NOTION-2 trial, in which investigators compared transcathe...
CathWorks’ FFRangio system gains approval under EU MDR
CathWorks has announced that the CathWorks FFRangio system has been approved under the European ...
First patient enrolled in BIOMAG-II trial of Freesolve resorbable scaffold
Biotronik has announced the enrolment of the first patient in the BIOMAG-II trial aiming to evaluate...
Global Heart Hub shares findings from the Patients living with Elevated Cholesterol data programme
Global Heart Hub, an international alliance of heart patient organisations, has shared the first fin...
IVUS-guided PCI comes out on top over angiography in trial in acute coronary syndrome patients
In patients with acute coronary syndrome (ACS), intravascular ultrasound (IVUS)-guided percutane...
Medtech Insights: Transcatheter tricuspid therapies “on the cusp of becoming standard of care”
The advance of transcatheter tricuspid replacement and repair technologies for the treatment of ...
Edwards’ Sapien 3 Ultra Resilia valve gets European launch
Edwards Lifesciences has announced the European launch of the Sapien 3 Ultra Resilia valve, a tr...
AltaValve granted US FDA breakthrough device designation
4C Medical Technologies has been granted breakthrough device designation by the US Food and Drug...
Advertorial: Handheld ultrasound: Providing a window into patients’ hearts at the point of care
This advertorial is sponsored by GE HealthCare
Experiencing symptoms like chest pain, shortness o...
Two-year echocardiographic data from REDUCE LAP-HF II trial published in JAMA Cardiology
Corvia Medical has announced the publication of two-year echocardiographic data from its REDUCE ...
Patient wellbeing and satisfaction improve without drop in safety after non-fasting strategy prior to cardiac catheterisation
Findings from the CALORI cardiac catheterisation trial, presented at the Society for Cardiovascular ...
Advertorial: TAVI in small aortic annuli: SMART trial underscores importance of choosing the right device
This advertorial is sponsored by Medtronic
Transcatheter aortic valve implantation (TAVI) has...
US analysis demonstrates superiority of radial access for PCI
New data demonstrate the superiority of radial arterial access compared to femoral arterial acce...
Nicolas Dumonteil
Medicine and indeed interventional cardiology were not initially on the radar for Nicolas Dumont...
Cardiovascular News – Issue 73 – May 2024: US Edition
In this issue:
Late-breaking studies from the American College of Cardiology (ACC) 2024 scienti...
Cardiovascular News – Issue 73 – May 2024: OUS Edition
In this issue:
Late-breaking studies from the American College of Cardiology (ACC) 2024 scienti...
SCAI 2024 hears additional analysis from SMART trial
Additional analysis from the SMART trial has demonstrated clinical non-inferiority of self-expan...
Medtronic’s Symplicity Spyral system approved for use in China
Medtronic has announced it received approval from the National Medical Products Administration (...
EACTS launches Innovation Hub to boost investment in surgical innovation
The European Association for Cardio-Thoracic Surgery (EACTS) has launched a new Innovation Hub, ...
PCI for stable coronary artery disease can be performed safely before, during or after TAVI
Percutaneous coronary intervention (PCI) can be safely performed before, during, or after transcathe...
Atrial fixation TMVR device may have reduced risk of LVOT obstruction
Results of the early feasibility study evaluating outcomes of the AltaValve (4C Medical) sub-val...
Performance of single-piece biomimetic transcatheter heart valve “encouraging”, first-in-man results indicate
Insights from the first-in-human study of the DurAVR (Anteris Technologies) biomimetic transcath...
Wattson temporary pacing guidewire begins limited market release
Teleflex has announced that the Wattson temporary pacing guidewire limited market release has commen...
Abbott’s Esprit BTK scaffold system given US FDA approval for CLTI treatment
Abbott has announced that the US Food and Drug Administration (FDA) has approved the Esprit BTK ever...
STS updates risk calculators for tricuspid surgery, CABG and SAVR after TAVI
The Society of Thoracic Surgeons (STS) has launched new risk calculators covering isolated tricuspid...
Medtronic announces US launch of Avalus Ultra surgical aortic valve
Medtronic has announced the launch of the Avalus Ultra surgical aortic tissue valve.
The valve is...
AATS joins as surgical partner of New York Valves meeting
The American Association for Thoracic Surgery (AATS) and the Cardiovascular Research Foundation (CRF...
Biotronik to distribute Texray radiation protection products
Biotronik has announced a multinational distribution partnership with Texray, the developer of a...
MAGICAL-ISR study of MagicTouch sirolimus DCB commences
Concept Medical has announced the commencement of its investigational device exemption (IDE) clinica...
Tria valves surpass 200 patient life years
Foldax has announced that its Tria valves have surpassed 200 patient life years in human recipie...
Fastwave Medical issued fourth utility patent for laser-IVL platform
FastWave Medical has announced the issuance of its fourth utility patent by the United States Patent...
Acolyte system for guidewire positioning and placement in CTOs given US FDA breakthrough device status
Simpson Interventions has announced that its Acolyte image-guided crossing and re-entry catheter sys...
Caranx Medical announces successful robotic TAVI procedure in an animal
Caranx Medical has announced the successful completion of a robotic transcatheter aortic valve impla...
Olivier Pierron joins Cardiawave SA as chief executive officer
Cardiawave SA has appointed of Olivier Pierron as its new chief executive officer. The company is de...
First large bore venous patient treated with PerQseal Elite vascular closure system
Vivasure Medical has announced the treatment of the first large bore venous patient with the PerQsea...
Transverse Medical restructures board as it seeks to bring cerebral embolic protection system to market
Transverse Medical, developer of the Point-Guard cerebral embolic protection device to protect the p...
Clinical study of CADScor system to identify non-obstructive coronary artery disease in chest pain patients gets underway
Acarix has announced the initiation of a US-based clinical study to collect real-world data to c...
ACC 2024: Use of Impella CP may boost survival in STEMI patients with cardiogenic shock
Use of the Impella CP (Abiomed) micro-axial flow pump in the treatment of patients with ST-segme...
ACC 2024: ORBITA-COSMIC shows reduction in chest pain in angina patients receiving coronary sinus reducer, but questions still remain
People with chronic chest pain who received a coronary sinus reducer (CSR, Shockwave Medical) ex...
Survey highlights lack of awareness of among women of heart valve disease and risk factors
Medtronic has unveiled top line findings of a survey on women's perceptions and knowledge of ris...
ACC 2024: Self-expanding valve comes out on top at one year in SMART trial comparing TAVI devices in small aortic annuli
Results of the SMART trial, comparing the use of two widely deployed transcatheter aortic valve ...
ACC 2024: Interatrial shunt fails to meet primary endpoint in RELIEVE-HF trial
Patients with heart failure who had an interatrial shunt inserted between the left and right atr...
Johnson & Johnson to acquire Shockwave Medical
Johnson & Johnson is to acquire Shockwave Medical, it has been announced today.
Under the ter...
ACC 2024: AEDs used in a small number of cardiac arrest cases, despite proximity
Automated external defibrillators (AEDs) were used in in 13 of nearly 1,800 cases of out-of-hosp...
One in 10 deaths after PCI found to be “preventable”, US state-wide analysis suggests
Around 10% of all deaths following percutaneous coronary intervention (PCI) are potentially preventa...
AI software integrated into GE Healthcare’s Vscan Air SL handheld ultrasound imaging system
GE HealthCare has announced the launch of Caption AI artificial intelligence (AI)-driven softwar...
Leadership change at TRiCares sees Atricure and Medtronic veteran join as president and CEO
TRiCares has announced the appointment of Ahmed Elmouelhi as president & chief executive off...
Debates to unpick controversies in aortic repair at CX 2024
Debates will shed new light on controversies in the treatment of aortic disease at the 2024 Char...
TriClip TEER system for TR repair given US FDA approval
Abbott has announced that the US Food and Drug Administration (FDA) has approved the company's TriCl...
PROTEMBO randomised trial of three-vessel cerebral embolic protection device enrols first patient
Protembis has announced the enrolment of the first patient in the PROTEMBO investigational device ex...
Winrevair given US FDA approval for the treatment of pulmonary arterial hypertension
Merck has announced the US Food and Drug Administration (FDA) has approved sotatercept-csrk (Winreva...
Cardiac surgeon and interventional cardiologist join egnite’s medical advisory board
egnite, a digital health company specialising in cardiovascular care, has announced the addition of ...
Latest-generation Evolut TAVI system gains US FDA approval
Medtronic has announced that the US Food and Drug Administration (FDA) has approved the Evolut F...
US registry launches to evaluate physician decision-making using HeartFlow Plaque Analysis
HeartFlow has announced the launch of the DECIDE registry, the largest prospective registry of its k...
ENVISION trial of Abbott’s Navitor TAVI valve in low-risk patients enrols first patient
Abbott has announced that the first patient has been enrolled in the ENVISION investigational device...
CRT 2024: Shield system cuts operator exposure to radiation during cath lab procedures
The use of a radiation shield system—Protego (Image Diagnostics)—could markedly cut the exposure...
CRT 2024: US DCB approval provides “important treatment option” for in-stent restenosis
The first US Food and Drug Administration (FDA) approval of a drug-coated balloon (DCB) for the ...
Robotic system “brings transcervical aortic valve replacement a step closer”
A company specialising in less invasive structural heart procedures has said that the first transcer...
BioCardia announces long-term partnership with StemCardia
BioCardia and StemCardia has a long-term partnership to advance StemCardia’s investigational pluripo...
Health Canada licenses Symplicity Spyral radiofrequency renal denervation system to treat hypertension
Medtronic has received a license from Health Canada for its Symplicity Spyral multi-electrode renal ...
Funding round closes in support of ConKay annuloplasty system for TR treatment
ConKay Medical Systems, a medtech start-up company developing a device for treating patients sufferi...
Global Cardiovascular Awards – The full list of winners and highly commended entries
Best Cardiovascular Product Launch– Siemens Healthineers: ARTIS Family
Best Medical Educati...
Past, present and future of cardiovascular innovation celebrated at Global Cardiovascular Awards
A founding father of transcatheter aortic valve implantation (TAVI), professor Alain Cribier (Un...
Cost-effectiveness and updated efficacy data from Evolut Low Risk trial shared at CRT 2024
Medtronic has announced two late-breaking data presentations on four-year outcomes from the Evol...
Gilbert Tang named as editor-in-chief of JACC: Case Reports
Cardiothoracic surgeon Gilbert Tang (Mount Sinai Health System, New York, USA) has been named ed...
Customising PCI with DES and DCB
This educational supplement, sponsored by Medtronic, explores the latest thinking around percutaneou...
ADVERTORIAL: TAVI offers promise in the “underdiagnosed and undertreated” aortic regurgitation population
This advertorial is sponsored by JenaValve
Transcatheter aortic valve implantation (TAVI) has...
HeartFlow shares ten-year data from DISCOVER-FLOW study
HeartFlow has announced that 10-year follow-up data from its DISCOVER-FLOW study were published ...
First mitral valve replacement performed using SSi Mantra robotic system
SS Innovations International has announced that surgeons have performed the world’s first mitral val...
CRT 2024: SAFE-MCS finds reduction in bleeding for high-risk PCI patients with bleed monitoring system
Saranas has announced results of SAFE-MCS, a multicentre clinical study evaluating the safety of com...
CRT 2024: New data on outcomes with Sapien TAVI platform
Results from two large, real-world studies assessing outcomes for patients undergoing transcathe...
US FDA approves weight loss drug Wegovy to prevent cardiovascular events
The US Food and Drug Administration (FDA) has approved an additional indication for the weight l...
PulseCath’s iVAC 2L gains MDR certification
PulseCath has announced the transition from CE marking to EU Medical Device Regulation (MDR) certifi...
Cleerly receives US FDA breakthrough designation for CAD staging system
Cleerly has been granted breakthrough device designation by the US Food and Drug Administration (FDA...
PROACTIVE-HF pivotal trial of Cordella pulmonary artery sensor meets primary endpoints
Six-month results from the PROACTIVE-HF pivotal trial, evaluating the Cordella pulmonary artery ...
Trial of autologous cell therapy in advanced chronic heart failure reports interim results at THT 2024
BioCardia has announced interim results from the phase III randomised controlled trial of its CardiA...
FastWave Medical gains third patent from USPTO for IVL system
FastWave Medical has announced the issuance of its third utility patent by the US Patent and Tradema...
Mobile clinical research specialist Hawthorne Effect appoints new CEO
Hawthorne Effect, a specialist in technology-enabled mobile clinical research, announced the app...
Boston Scientific’s Agent DCB gains first US FDA coronary approval
Boston Scientific has announced that it has received US Food and Drug Administration (FDA) approval ...
EACTS and STS guidelines recognise aorta “as an organ in its own right”
New guidelines from the European Association for Cardio-Thoracic Surgery (EACTS) and the Society...
Patient enrolment completed in study of remote heart failure monitoring device
FIRE1 today announced that it has completed patient enrolment in the US early feasibility study—FUTU...
First patient treated using A-Flux Reducer interventional system for angina
VahatiCor has announced the treatment of the first patient with the A-Flux Reducer system, an in...
Renal denervation finds new shores following US FDA device approvals
Like London buses, interventionalists have had a long wait for the US Food and Drug Administrati...
Settling the paclitaxel versus sirolimus DCB debate
Bernardo Cortese (Fondazione Ricerca e Innovazione Cardiovascolare, Lodi, Italy and DCB Academy) has...
Challenges establishing minimally invasive cardiac surgery in the developing world
Attaulah Khan Niazi (King Edward Medical University, Lahore, Pakistan) documents the major challenge...
Foldax agrees manufacturing agreement with Dolphin Life Science India
Foldax has announced a manufacturing agreement with Dolphin Life Science India to enable in-coun...
First cases using Laminar LAAX system performed as part of IDE study
Biosense Webster has announced the commencement of patient cases with the investigational Laminar le...
Ismail El-Hamamsy named as president of Heart Valve Society
Ismail El-Hamamsy, director of aortic surgery for the Mount Sinai Health System (New York, USA),...
First procedure completed using Laplace tricuspid valve replacement system
Laplace Interventional has announced the successful completion of its first-in-human (FIH) proce...
Cardiovascular News – Issue 72 – February 2024: OUS Edition
In this issue:
New data point to shift towards TAVI in patients aged under 60
ORBITA-2 trial...
Cardiovascular News – Issue 72 – February 2024: US Edition
In this issue:
New data point to shift towards TAVI in patients aged under 60
ORBITA-2 trial...
Todd Berg joins NeoChord as CEO
NeoChord has appointed Todd Berg as chief executive officer to oversee clinical and commercial prog...
Ajay Kirtane
For Ajay Kirtane (Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York,...
Analyses provide “hard evidence” of benefit of intravascular imaging-guided PCI
Two meta-analyses comparing the use of intravascular imaging to angiography for the guidance of ...
Australian government offers grant support to artificial heart programme
BiVACOR, a clinical-stage medical device company, has announced that US$13 million has been awarded ...
Reprieve Cardiovascular secures multimillion dollar financing
Reprieve Cardiovascular, a development stage company focused on pioneering an automated diuretic and...
Global registry charts pandemic’s impact on TAVI volumes
Transcatheter aortic valve implantation (TAVI) procedures were more acutely impacted during the ...
Alain Cribier: 1945–2024
Alain Cribier, the pioneering cardiologist who performed the world’s first transcatheter aortic ...
TriClip gets positive vote from US FDA advisory panel
The Circulatory System Devices Panel of the Medical Devices Advisory Committee for the US Food and D...
Biotronik’s Freesolve resorbable magnesium scaffold gains CE mark
Biotronik has announced the CE approval and launch of the Freesolve resorbable magnesium scaffold (R...
BHF PROTECT-TAVI trial poised to answer key questions about use of cerebral embolic protection during TAVI
Investigators behind the largest randomised trial to date to assess the use of cerebral embolic ...
FLOWer embolic protection device gains CE mark
AorticLab has announced CE mark certification for the FLOWer transcatether embolic protection device...
Biotronik launches Micro RX microcatheter to the US market
Biotronik has launched the Micro Rx novel rapid exchange microcatheter to enhance guidewire support ...
Study of TIVUS renal denervation system for hypertension treatment completes enrolment
The REDUCED-1 study, a US Food and Drug Administration (FDA) investigational device exemption (IDE)-...
Health Canada approves VenusP-Valve transcatheter pulmonic valve replacement system
Venus Medtech has announced that the VenusP-Valve transcatheter pulmonic valve replacement (TPVR) sy...
Early feasibility study of TAVI platform for treatment of aortic regurgitation completes enrolment
Genesis MedTech has announced the completion of enrolment in its US early feasibility study (EFS) us...
STS 2024: Large registry study demonstrates superiority of multi-arterial grafting for multivessel revascularisation
A study of more than one million patients undergoing isolated coronary artery bypass graft (CABG...
Evoque becomes first transcatheter tricuspid system to gain US FDA approval
Edwards Lifesciences has announced that its Evoque tricuspid valve replacement system is the fir...
AF Symposium 2024: AI-enabled predictive pre-planning “significantly improves LAAO procedural efficiency”
Data from the first US comprehensive single-centre experience at St Bernard’s Medical Center and Arr...
Cast your vote for the Heart Team of the Year
Two specialist heart teams are vying to win the Heart Team of the Year Award at the first Global Car...
SCAI publishes expert consensus statement on calcified coronary lesions
A newly published Society for Cardiovascular Angiography and Interventions (SCAI) expert consens...
Philips’ “mini” 3D TEE transducer granted US FDA approval
Royal Philips has received US Food and Drug Administration (FDA) 510(k) clearance for its X11-4t tra...
STS 2024: STS elects its first female president
Jennifer C Romano has been named president of the Society of Thoracic Surgeons (STS), the first ...
STS 2024: Data show shift in the proportion of patients under 60 receiving TAVI instead of SAVR
Research presented at the 60th annual meeting of the Society of Thoracic Surgeons (STS 2024; 27–...
French registry study finds fewer cardiovascular deaths among mitral regurgitation patients receiving TEER
The results of a propensity-matched analysis of all patients undergoing mitral valve surgery or tran...
Early feasibility study of CroíValve’s Duo tricuspid coaptation valve system launches
CroíValve has announced the initiation of its early feasibility study (EFS) for the Duo tricuspid co...
Collaboration aims to develop a bespoke cell phenotyping assay for human blood
PlaqueTec, a company identifying endotype-specific biomarkers to advance precision medicine for coro...
Three valve-in-valve procedures completed using DurAVR transcatheter valve
Anteris Technologies has announced the successful completion of three new valve-in-valve (ViV) cases...
US FDA grants breakthrough designation for Pi-Cardia’s ShortCut leaflet splitting device
Pi-Cardia has received breakthrough device designation from the US Food and Drug Administration (FDA...
See the full shortlist for the Global Cardiovascular Awards
The full shortlist for the inaugural Global Cardiovascular Awards—which will recognise the tireless ...
First-in-human implant of Triflo heart valve completed
Novostia has announced the successful first-in-human implantation of its Triflo aortic valve.
The...
Radiofrequency renal denervation meets cost efficiency threshold in value analysis
An analysis of data from the SPYRAL HTN-ON MED trial of the Symplicity Spyral (Medtronic) radiof...
FastWave Medical announces completion of first procedures in study of novel peripheral IVL system
FastWave Medical has announced the successful completion of enrolment for its first-in-human (FI...
Study shows no safety risk in allowing patients to eat prior to cardiac catherisation
Allowing patients to eat before elective cardiac catheterisation posed no safety risk and benefited ...
“Structural heart leader” joins Cardiac Dimensions as chief medical officer
Cardiac Dimensions, a developer of invasive treatment modalities to address patients suffering f...
Penumbra launches Indigo system CAT RX catheter in Europe to treat acute coronary syndrome
Penumbra has secured CE mark for its Indigo system CAT RX designed to address the limitations of tra...
Occlutech to launch atrial septal defect occluder in the USA
Occlutech has announced that the US Food and Drug Administration (FDA) has approved the Occlutech AS...
US FDA grants clearance for VR surgical planning software from Realize Medical
Realize Medical has announced that its virtual reality (VR) software for surgical planning, Elucis, ...
First patient randomised in BACKBEAT study of AVIM therapy for uncontrolled hypertension
Orchestra BioMed Holdings has announced the first patient was randomised in the BACKBEAT pivotal stu...
US FDA approves ENGULF US pivotal trial of Hēlo thrombectomy system
Endovascular Engineering (E2) has announced US Food and Drug Administration (FDA) investigational de...
Medical cannabis for chronic pain may increase risk of arrhythmia
People taking medical cannabis for chronic pain have a slightly increased risk of arrhythmia, ac...
GE HealthCare to acquire AI-imaging specialist
GE HealthCare has entered into an agreement to acquire MIM Software, a provider of artificial intell...
R-One robotic platform given green light to enter Chinese market
Robocath has announced the granting of a marketing authorisation to distribute its R-One robotic pla...
Endotronix submits premarket approval application to US FDA for Cordella pulmonary artery sensor
Endotronix has submitted a premarket approval (PMA) application for its Cordella pulmonary arter...
Edwards Lifesciences appoints its first US case observation site under Benchmark TAVI programme
Eisenhower Health (Rancho Mirage, USA) is the first hospital in the USA to become an Edwards Ben...
Topaz tricuspid valve replacement system used for the first time in a patient with a pacemaker
TRiCares SAS has announced the successful implantation of its Topaz transfemoral tricuspid heart val...
Chilean centre treats five aortic regurgitation patients in a single day with Zeta TAVI system
Laguna Tech USA has announced that a record number five patients were successfully treated at a sing...
HeartFlow’s FFRCT analysis passes 250,000 patient milestone
HeartFlow, a developer of non-invasive artificial intelligence (AI) precision coronary care solu...
Pulse Biosciences files premarket US FDA 510(k) notification for its CellFX nsPFA cardiac clamp
Pulse Biosciences has filed a premarket notification 510(k) to the US Food and Drug Administration (...
Investors offer backing for developer of transcatheter mitral chord repair technology
Norway-based CardioMech AS, a medical device company developing a transfemoral, transseptally de...
First patient treated in ARISE II study of Gore ascending stent graft
Gore has announced the first patient implantation of the Gore ascending stent graft in the ARISE II ...
Cardiovascular News’ top stories of 2023
Which stories, features and interviews captured the attention of the cardiovascular community across...
Blood potassium monitor under development to benefit patients with chronic renal failure
CardioRenal and CHU Grenoble Alpes have announced an innovation that allows chronically ill patients...
LUMA Vision secures US$22 million in financing
LUMA Vision, developer of a novel four-dimensional (4D) cardiac imaging and navigation platform,...
CE mark trial of Optimum TAVI valve given green light for expansion
Thubrikar Aortic Valve has received authorisation from the Competent Authority of Poland to expand t...
Microbot Medical and Corewell Health announce telerobotics collaboration
Microbot Medical, developer of the Liberty endovascular robotic surgical system, has entered into a ...
Early use of mechanical support shows benefit for patients with AMI complicated by cardiogenic shock
Results of the National Cardiogenic Shock Initiative—a single-arm multicentre study assessing the fe...
ANGIODAPT trial launches with first patient enrolment
iVascular has announced the initiation of its first randomised trial of an abbreviated dual antiplat...
First-in-man cross-country robotic coronary angioplasty performed in two Chinese centres
Robocath has announced a first-in-human robotic coronary angioplasty performed at a distance of 1,70...
First patient treated with PerQseal Elite vascular closure system
Vivasure Medical has announced the first patient treated with PerQseal Elite, the latest generation ...
Haemonetics completes acquisition of OpSens
Haemonetics Corporation has completed its acquisition of OpSens, the company announced in a press re...
Consortium to assess use of CT to improve diagnosis and treatment of coronary artery disease
A public-private partnership, involving input from clinical and industry partners, will investigate ...
Mortality from cardiovascular disease continues to increase globally
Cardiovascular diseases, including ischaemic heart disease, stroke, heart failure, peripheral and ao...
Pi-Cardia appoints Gary Gratson to lead commercialisation of ShortCut
Pi-Cardia has appointed Gary Gratson to lead commercial operations for ShortCut, its dedicated l...
Warfarin lowers mortality risk after SAVR
Patients who received warfarin after bioprosthetic aortic valve replacement had lower incidence of m...
Harlan M Krumholz named as JACC editor-in-chief
The cardiologist and researcher, Harlan M Krumholz (Yale School of Medicine, New Haven, USA), ha...
Projected rise in aortic valve-in-valve procedures prompts interest in leaflet splitting device
Details of the first pivotal trial assessing the use of a dedicated leaflet splitting device to ...
Catheter Precision’s VIVO 3D mapping system secures reimbursement in NHS England’s SSDP
Healthcare 21 (HC21) has gained national reimbursement for Catheter Precision’s VIVO 3D mapping syst...
Kaneka Corporation acquires Japan Medical Device Technology Co
Kaneka Corporation has acquired all shares of Japan Medical Device Technology Co and has made it a w...
Profiling plaque to guide treatment of coronary artery disease
Investigators behind the BIOPATTERN trial hope that their work will shape the understanding of w...
Carmat increases capacity with opening of second production facility
Carmat has opened a second production facility in Bois-d'Arcy.
Works on the site, which is in the...
Medtronic launches Penditure left atrial appendage exclusion system in the USA
Medtronic has announced the launch of its Penditure left atrial appendage (LAA) exclusion system...
First patients join pivotal trial of Aortix pump for treatment of acute decompensated heart failure
Procyrion has announced the enrolment of the first patients in the company’s investigational dev...
Johnson & Johnson acquires Laminar
Johnson & Johnson MedTech has announced the completion of the acquisition of Laminar, a medical ...
Next-generation Palmetto TMVR system gets first-in-man use
ReValve Solutions has announced the successful first-in-human use of its Palmetto transcatheter mitr...
Bivacor gets US FDA nod for early feasibility of its total artificial heart
The US Food and Drug Administration (FDA) has given the green light for commencement of an investiga...
BIOPATTERN trial seeks precision approach to coronary artery disease treatment
PlaqueTec has received approval from UK’s Medicines and Healthcare products Regulatory Agency (M...
Enrolment in Indian clinical trial of Tria mitral valve completed
Foldax has announced completion of enrolment in the Indian clinical trial of the TRIA polymer su...
First patient enrolled in RECOVER IV randomised trial of Impella in AMI patients
Abiomed has announced that the first patient in the world has been enrolled in the landmark RECOVER ...
AF after mitral valve surgery “has a strong negative influence on survival”
The occurrence of atrial fibrillation (AF) after mitral valve surgery may be more harmful than previ...
EACTS panel sounds call to action over sex disparities in coronary surgery
A historic underrepresentation of women in clinical trials for coronary artery bypass graft (CAB...
Low-risk TAVI trials underscore optimism for transcatheter approach but surgical societies reserve caution
“It has been a good day for TAVI ,” commented Raj Makkar (Cedars-Sinai, Los Angeles, USA) at thi...
Clinical outcomes similar at one-year for leading TAVI platforms in real-world registry, but stroke rates differ
A comparison of two latest-generation self-expanding and balloon-expandable transcatheter aortic...
AI-derived risk score may improve planning of TEER for secondary mitral regurgitation
A novel risk score derived from artificial intelligence (AI) may be more effective than currentl...
SCAI: First US renal denervation approvals “revolutionise” treatment of uncontrolled hypertension
The approval of two renal denervation devices by the US Food and Drug Administration (FDA)—the Parad...
Supira Medical to initiate US clinical programme for pVAD system
Supira Medical announced today that it has received US Food and Drug Administration (FDA) breakt...
Roadmap launched to guide shared decision-making in heart valve disease treatment
Global Heart Hub, an international alliance of heart patient organisations, has published an impleme...
Medtronic’s Symplicity Spyral renal denervation system granted US FDA approval for hypertension treatment
Medtronic has announced approval from the US Food and Drug Administration (FDA) for the Symplicity S...
JenaValve partners with American Society of Echocardiography to increase awareness of aortic regurgitation
JenaValve Technology has announced that it will join the American Society of Echocardiography (ASE) ...
ADVERTORIAL: NOTION trial results crystallise long-term thinking on TAVI versus SAVR
This advertorial is sponsored by Medtronic
With transcatheter aortic valve implantation (TAVI...
Jolanda Kluin
Inspired by a passion for nature, Jolanda Kluin began her career in medicine in Africa, before retur...
Cardiovascular News – Issue 71 – November 2023: OUS Edition
In this issue:
Low-risk TAVI trials spark optimism, but surgical societies urge caution over a ...
Cardiovascular News – Issue 71 – November 2023: US Edition
In this issue:
Low-risk TAVI trials spark optimism, but surgical societies urge caution over a ...
ARIES trial shows LVAD patients who did not receive aspirin had fewer bleeding complications
Abbott has announced new late-breaking data that show advanced heart failure patients living wit...
ACCESS-MANTA registry to assess use of Manta vascular closure device in TAVI procedures
Teleflex has announced the first patient enrolment in a clinical registry that is intended to examin...
TRANSFORM trial to explore personalised strategy for cardiovascular disease prevention
Cleerly has announced the TRANSFORM trial a randomised trial that aims to enroll 7,500 patients ...
VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations
New analyses from the VOYAGER PAD clinical trial in both high-risk and fragile patients and thos...
First-in-human study explores safety and feasibility of Captis embolic protection device during TAVI procedures
Filterlex Medical has announced the publication of a first-in-human (FIH) study EuroIntervention...
EECP therapy results “promising” for ANOCA patients
Enhanced external counterpulsation (EECP, Flow Therapy), a non-invasive treatment that increases...
PATCH clinical study of PerQseal vascular closure system reaches 100-patient milestone
Vivasure Medical has enrolled the 100th patient in its PATCH clinical study, a multicentre, sing...
First-in-human results of non-invasive ultrasound therapy for aortic stenosis published in The Lancet
Results from first-in-human (FIH) clinical studies on 40 patients suffering from calcific aortic ste...
First implant of ChordArt TMVR system completed
CoreMedic has announced the first successful application of its ChordArt transcatheter technology fo...
AHA 2023: RCE Technologies wins Health Tech competition
RCE Technologies, the developer of a non-invasive, instant measurement of cardiac proteins was s...
SELECT trial shows cardiovascular risk reduction in non-diabetics taking semaglutide
Results of the SELECT clinical trial, presented at the American Heart Association’s 2023 Scientific ...
Xenter unveils dual-sensor TAVI guidewire
Xenter unveiled its dual sensor investigational guidewire for transcatheter aortic valve implantatio...
PCI improves angina symptoms without medication in ORBITA-2 trial
Percutaneous coronary intervention (PCI) relieves stable chest pain and improves exercise capaci...
Data and debate to bring new light to aortic controversies at CX 2024
The aortic programme at the 2024 Charing Cross (CX) Symposium (23–25 April, London, UK) promises to ...
Medinbox launches latest proctoring and remote learning platform for cath labs
Medinbox has launched its latest product suites to enhance live collaboration for medical educat...
Scott Drake appointed as Cordis CEO
Cordis has announced that its board of directors has appointed Scott Drake as chief executive of...
Recor Medical gains first US FDA renal denervation approval
Recor Medical has become the first company in the USA to have a device-based therapy approved fo...
CONFORMAL EFS results shared out to one year at TCT 2023
Conformal Medical has announced positive one-year results from the company's CONFORMAL Early Fea...
No difference in outcomes for AF patients undergoing LAAO and TAVI at the same time
Patients with atrial fibrillation (AF) undergoing a transcatheter aortic valve implantation (TAV...
E2 shares positive initial results from use of Hēlo system for acute sub-massive pulmonary embolism treatment
Endovascular Engineering (E2) has announced positive initial results from its ENGULF study, demonstr...
First patients enrolled in coronary de novo trial of Selution SLR drug-eluting balloon
Cordis has announced enrolment of the first patient in its SELUTION4DeNovo IDE trial, the coronary d...
TCT 2023: TAVI system for aortic regurgitation shows promise in ALIGN AR trial
Positive results from the ALIGN AR pivotal trial, investigating the use of the Trilogy (JenaValv...
First patients treated with Laguna Tech’s Alpha and Zeta aortic valves
Laguna Tech USA has announced that the first-in-human clinical case was completed with the Zeta ball...
Edwards Lifesciences’ Mitris Resilia valve receives CE mark for mitral replacement surgeries
Edwards Lifesciences has received CE mark for the Mitris Resilia tissue valve replacement specifical...
TCT 2023: TRILUMINATE quality of life data point to benefit for patients with severe TR undergoing TEER
Analysis of health status and quality of life data from the TRILUMINATE Pivotal trial, presented...
TCT 2023: Initial phase of TRISCEND II trial of Evoque transcatheter replacement for severe tricuspid regurgitation meets primary endpoints
A randomised trial comparing transcatheter tricuspid valve replacement (TTVR) with the Evoque sy...
TCT 2023: Agent DCB shows superiority to conventional balloon angioplasty for target-lesion failure in US randomised trial
The first US randomised trial investigating the safety and efficacy on the use of a drug-coated ...
TCT 2023: Five-year PARTNER 3 results “reaffirm” role of TAVI as alternative to surgery in low-risk patients
Five-year data from the PARTNER 3 trial, which randomised low surgical risk aortic stenosis pati...
TCT 2023: Intellistent multi-lumen stent system for pulmonary arterial hypertension wins Shark Tank innovation prize
HeartPoint Global was named winner in the Shark Tank Innovation Competition at the 2023 TCT conferen...
Medinol’s EluNIR-PERL coronary stent gains US FDA approval
Medinol today announced US Food and Drug Administration (FDA) approval for the EluNIR-PERL drug-...
TCT 2023: EVOLUT Low Risk trial shows continued strong performance for self-expanding TAVI platform out to four years
At four years of follow-up, patients with severe aortic stenosis at low risk for surgery undergo...
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the US FDA
Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) ...
GE HealthCare’s Allia IGS Pulse imaging system approved by the US FDA
GE HealthCare has announced US Food and Drug Administration (FDA) 510(k) clearance of Allia IGS Puls...
RELIEF clinical study of PFO closure for migraine relief begins randomisation
Patients have passed through the multi-month enhanced screening process and have begun entering ...
Multicentre study points to favourable safety and efficacy of radial access for peripheral interventions
New research examining the safety and efficacy of using radial access for peripheral artery inte...
Site-less model helps to improve diversity in PREVUE-VALVE study
Researchers behind a trial to quantify the true prevalence of valvular heart disease within the USA ...
Medtronic receives CE mark for Evolut FX TAVI system to treat severe aortic stenosis
Medtronic has received CE mark for the Evolut FX transcatheter aortic valve implantation (TAVI) syst...
EACTS 2023: Registry study finds “significantly increased” all-cause mortality among older patients selected for TAVI versus SAVR
A population-based cohort study of patients treated in the Austrian healthcare system has found ...
OpSens and Haemonetics enter into acquisition agreement
OpSens has entered into a definitive arrangement agreement with Haemonetics Corporation that will se...
FEops HEARTguide LAA workflow integrated into TeraRecon software
FEops has entered into a partnership with ConcertAI’s TeraRecon for the commercialisation of FEo...
US FDA grants IDE approval for PROACTIVE-HF 2 study of Cordella pulmonary artery sensor
Endotronix has received investigational device exemption (IDE) approval from the US Food and Dru...
EACTS 2023: On-X aortic valve “remains safe and effective with low dose warfarin”
Data from the On-X aortic heart valve low INR post-market study, presented during a late-breakin...
Elixir Medical submits approval for DynamX coronary bioadaptor in Japan
Elixir Medical has announced submission to Japan’s Pharmaceutical and Medical Device Agency (PMD...
EACTS 2023: Statin treatment may benefit SAVR patients
Ongoing statin treatment may be beneficial for patients after isolated surgical aortic valve rep...
US FDA approval for AI-powered left ejection fraction detection device
Anumana has announced US Food and Drug Administration (FDA) 510(k) clearance for ECG-AI LEF, a break...
MedAlliance acquired by Cordis
MedAlliance has been acquired by Cordis for a 2022 investment of US$35 million and a 2023 upfront cl...
US FDA grants conditional IDE approval for F2 cerebral embolic protection system
EnCompass Technologies has announced that the US Food and Drug Administration (FDA) has granted cond...
Boston Scientific gains US FDA clearance for AVVIGO+ multi-modality guidance system
Boston Scientific has announced US Food Administration (FDA) clearance of the AVVIGO+ multi-modality...
Surgeons perform historic second transplant of a genetically modified pig heart into a human
Surgeons at the University of Maryland Medical Center (UMMC, Baltimore, USA) have performed the seco...
Nitrate reduces contrast-induced necropathy during coronary angiography
Inorganic nitrate reduces contrast-induced nephropathy (CIN), improves renal outcomes and reduces ca...
Nick West appointed to associate CMO role at Shockwave Medical
Shockwave Medical has announced that Nick West has joined the company in the role of associate c...
David Hildick-Smith
As one of the UK’s leaders in interventional cardiology, David Hildick-Smith (University Hospitals S...
Cardiovascular News – Issue 70 – September 2023: US Edition
In this issue:
Societies weigh in on renal denervation as US Food and Drug Administration (FDA)...
Cardiovascular News – Issue 70 – September 2023: OUS Edition
In this issue:
Societies weigh in on renal denervation as US Food and Drug Administration (FDA)...
Pivotal study of ShortCut leaflet splitting device completes enrolment
Pi-Cardia has announced the successful completion of its ShortCut pivotal study enrolment.
ShortC...
ADVERTORIAL: Hypertension guidelines “change the thinking” on renal denervation
This advertorial is sponsored by Medtronic
Hypertension is a leading cause of heart attack, strok...
European survey highlights lack of uniformity in heart team implementation
A survey of cardiac surgeons and interventional cardiologists from 26 European nations has highlight...
Updates to HyperVue intravascular imaging system approved by US FDA
SpectraWAVE has announced US Food and Drug Administration (FDA) 510(k) clearance for product enhance...
Enrolment complete in SAFE-MCS study of Early Bird bleed monitoring system
Saranas has completed enrolment in SAFE-MCS, a multicentre, single arm, open-label clinical trial ev...
Half of patients enrolled in SELUTION DeNovo coronary trial
MedAlliance has announced enrolment of over 1,660 patients in its SELUTION DeNovo coronary randomise...
Large annulus valve launched for transseptal mitral valve replacement system
HighLife SAS has announced the introduction of a new valve size in its clinical trials of a transsep...
Ten-year NOTION trial data provide important insights on long-term TAVI outcomes and valve durability
Ten-year data from the NOTION trial—the longest-running clinical trial to date to compare outcom...
Watchman FLX Pro gains US FDA approval
Boston Scientific has received US Food and Drug Administration (FDA) approval for the latest-gen...
Enrolment begins in LOVE-DEB study of Selution SLR sirolimus-eluting balloon
The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease tr...
First-in-man procedure follows US FDA breakthrough designation for NyokAssist PVAD system
The first-in-man (FIM) use of the NyokAssist (magAssist) percutaneous ventricular assist device ...
ESC 2023: Study assesses impact of using Heartflow FFRCT for diagnosing coronary artery disease
A study assessing the impact of the addition of adding coronary computed tomography angiography ...
Sirolimus-eluting Orsiro stent non-inferior to zotarolimus-eluting device in BIOFLOW-DAPT trial
One-year-data from the BIOFLOW-DAPT trial demonstrated non-inferiority and a good safety profile for...
Stroke expert J Mocco joins Protembis board
Protembis has announced the appointment of J Mocco (Icahn School of Medicine at Mount Sinai, New Yor...
Radiaction Medical secures Series C2 funding and announces board addition
Radiaction Medical has raised US$12.6 million in Series C2 funding led by US private equity fund Inn...
UK MHRA adds capacity for medical device certification
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new app...
ESC 2023: Prolonged clopidogrel monotherapy after PCI in high-risk ACS patients reduces bleeding and ischaemic events
Extended P2Y12 inhibitor monotherapy beyond 12 months after percutaneous coronary intervention (PCI...
ESC and EACTS conclude review of left main revascularisation guidelines recommendations
A joint review of evidence into the treatment of patients at low surgical-risk with left main corona...
ESC 2023: ECLS not shown to improve survival in patients with acute MI complicated by cardiogenic shock
Early extracorporeal life support (ECLS) does not improve survival in patients with acute myocar...
ESC 2023: ADVENT trial shows PFA is non-inferior to thermal ablation for safety and efficacy in paroxysmal AF
Results of the first randomised trial comparing pulsed field ablation (PFA) to thermal ablation ...
ESC 2023: GE Healthcare showcases latest-generation handheld ultrasound scanner and AF tool
GE Healthcare has announced the launch of two new tools for the cardiology market, coinciding wi...
ESC 2023: Hot Line trials add weight to case for intravascular imaging during PCI
Data from three randomised trials and a meta-analysis presented at the European Society of Cardi...
ESC 2023: Siemens unveils Acuson Origin imaging platform
Siemens Healthineers has unveiled the Acuson Origin, a dedicated cardiovascular ultrasound system wi...
SCAI: FDA panel vote “encouraging” for advance of renal denervation
The Society for Cardiovascular Angiography & Interventions (SCAI) has welcomed the review of sci...
FDA panel split on risk and benefit of Symplicity Spyral renal denervation system
The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel met yesterday (23 Au...
First two US patients receive Trisol tricuspid valve
The heart teams at the Piedmont Heart Institute (Atlanta, USA) and the University of Virginia He...
FDA panel votes favourably on safety and efficacy of Paradise renal denervation system
The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices A...
ESC 2023: Risk of MI recurrence higher in patients who do not take daily aspirin
Myocardial infarction (MI) patients who do not take daily aspirin have an elevated likelihood of rec...
Elevate pLVAD completes early feasibility study
Enrolment has been completed in the US Food and Drug Administration (FDA)-approved early feasibility...
Advanced NanoTherapies secures investment for development of SirPlux Duo DCB
Advanced NanoTherapies—ANT—has announced the completion of a US$4million Series A extension from...
SCAI position statement “aims to pave the way for renal denervation in the management of hypertension”
The Society for Cardiovascular Angiography & Interventions (SCAI) has released a position statem...
Bryan Williams joins BHF as research leader
The British Heart Foundation (BHF) has appointed research leader and NHS consultant physician Br...
Sham-controlled trials prompt renal denervation hypertension guideline update
Latest research in the field of renal denervation has prompted its inclusion in updated guidelin...
Forxiga granted approval from China’s NMPA for treatment of symptomatic chronic heart failure
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China for use in adults with symptomatic ...
First patient enrolled in global study of heart failure device trial
Heart failure start-up Acorai has announced the initiation of a global clinical trial with the e...
AI model may improve detection of atrial septal defect
An artificial intelligence (AI) model may be more efficient at detecting signatures of atrial septal...
Efforts needed to improve cardiovascular research in Africa
Research published in the journal Circulation: Cardiovascular Quality and Outcomes has highlight...
STS risk calculator uses power of big data to predict cardiac surgery risk
A new digital tool launched by the Society of Thoracic Surgeons (STS) draws together data from m...
US FDA grants de novo approval for AI-based HCM detection algorithm
Viz.ai has received a de novo approval by the US Food and Drug Administration (FDA) for its Viz ...
STAR-T trial of DrugSorb-ATR completed
CytoSorbents has announced the completion of the pivotal STAR-T (Safe and Timely Antithrombotic Remo...
Orchestra BioMed gains FDA nod to begin study of Virtue SAB sirolimus balloon
Orchestra BioMed Holdings has been granted US Food and Drug Administration (FDA) investigational dev...
First US implants mark start of DurAVR THV early feasibility study
Anteris Technologies has reported that its DurAVR biomimetic, single-piece transcatheter aortic ...
Ilika and Cirtec Medical partner on manufacture and commercialisation of Stereax solid-state batteries
Ilika and Cirtec Medical have announced that they have signed a 10-year manufacturing licence to pro...
VenusP-Valve gains FDA authorisation for transpacific clinical study
Venus Medtech has announced US Food and Drug Administration (FDA) Investigational Device Exemption (...
Canon Medical launches Alphenix / Evolve Edition angiography system in Europe
Canon Medical has introduced its Alphenix / Evolve Edition angiography system for commercial sale in...
“Not just inventing the next stent”: The future of medtech relies on patient empowerment
Ian Meredith is a well-known figure within the field of interventional cardiology, not only for ...
Cardiovascular News’ top 10 stories of July 2023
Hitting the headlines in July were new European guidelines on the treatment of arterial hyperten...
CMS creates new MS-DRG codes and payments for coronary IVL
Shockwave Medical has announced that as part of the Fiscal Year 2024 Medicare Hospital Inpatient Pro...
WHO adds cardiovascular polypill to essential medicines list
The World Health Organization (WHO) has included a cardiovascular polypill—an all-in-one pill contai...
TaurusTrio TAVI device gets first implants in aortic regurgitation clinical study
Peijia Medical has announced that the first Chinese patient has been enrolled in the clinical trial ...
Laplace Interventional secures funding for clinical testing of transcatheter tricuspid valve technology
Laplace Interventional, a medical device company developing a transcatheter tricuspid valve tech...
First patients treated in Indian clinical trial of Tria surgical mitral valve
Foldax has announced that the first 30 patients have been treated outside of the USA in the Indi...
Transfemoral TAVI device gains US FDA breakthrough status for aortic regurgitation
Genesis MedTech has announced that its J-Valve transfemoral (TF) system has been granted breakthroug...
Study confirms AI detection of HFpEF using a single echocardiogram view
Applying artificial intelligence (AI) to a single apical four chamber (A4C) view echocardiogram ...
Results from studies of HeartFlow coronary technologies shared at SCCT conference
Respective results from the REVEALPLAQUE, DECODE, and SMART-CT were presented at the Society of ...
First valve-in-valve procedure performed with DurAVR transcatheter valve
Anteris Technologies has announced that the DurAVR transcatheter heart valve (THV) was used for ...
CardioPrecision moves into US market
CardioPrecision, a developer of less invasive treatment solutions for structural heart disease, has ...
EACTS puts innovation to the fore
Innovation is a part of the DNA of cardiothoracic surgery, Friedhelm Beyersdorf (Heart Center Fr...
Michael Jaff joins board of directors at HeartBeam
HeartBeam, developer of a 3D-vector electrocardiogram (VECG) platform, has announced the appoint...
Clinical trial to compare PCI and CABG in women and minorities
Researchers will carry out the first clinical trial focusing on women and minority populations t...
Extreme temperatures and particulate pollution may increase MI mortality risk
The combination of soaring heat and fine particulate pollution may double the risk of myocardial inf...
Global Cardiovascular Awards to recognise excellence and innovation in cardiovascular care
Entries are now open for the inaugural edition of the Global Cardiovascular Awards, a recognition sc...
Onecrea Medical announces successful first-in-human implants of Crea aortic valve
Onecrea Medical has announced the success of the first-in-human implants of its transcatheter aortic...
PECA Labs appoints new board members
PECA Labs has added Jeffrey P Carpenter, Jeffrey O’Donnell Sr and Samuel E Navarro to its board of d...
SCAI welcomes FDA decision to remove red flag for use of paclitaxel-coated devices in PAD
The president of the Society for Cardiovascular Angiography & Interventions (SCAI), George D...
Ian Meredith joins board of directors at Avertix Medical
Avertix Medical—formerly known as Angel Medical Systems—has announced that Ian Meredith has agre...
TIMELY study will assess impact of AI platform on health of MI patients with coronary disease undergoing cardiac rehabilitation
The TIMELY consortium announced today the enrolment of the first patient in the randomised controlle...
ESH guidelines represent a “significant milestone” for hypertension management
ReCor Medical and its parent company Otsuka Medical Devices have welcomed the release of updated...
INFINITY-SWEDEHEART trial of DynamX bioadaptor system completes enrolment
Elixir Medical has announced enrolment completion in INFINITY-SWEDEHEART, a prospective, multice...
Randomised trial “highly needed” to shed light on effectiveness of TAVI in bicuspid aortic stenosis patients
A dedicated, prospective randomised controlled trial (RCT) investigating the safety, efficacy and li...
Patient advocacy group says ESH guideline change will improve access to renal denervation
Citizens of Europe at risk for heart attacks, stroke and chronic kidney disease due to uncontrolled ...
HOST-IDEA sub-analysis uncovers differences in ultrathin stent platforms
Results of a stent-level analysis from the HOST-IDEA study, which compared two ultrathin strut d...
Gut bacteria linked to coronary atherosclerotic plaques
In a major Swedish study, researchers have discovered a link between the levels of certain bacte...
Timeline: Key milestones in the paclitaxel story
The release of a letter from the US Food and Drug Administration (FDA) concerning the use of paclita...
Approval granted to commence study of renal pelvis denervation system
Verve Medical has received approval from the US Food and Drug Administration (FDA) to initiate its N...
First US patients implanted with FIRE1 remote heart failure monitoring system
FIRE1 has announced that the first US patients have been successfully implanted with its FIRE1 syste...
Long-awaited US FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA...
First patient enrolled in MOJAVE study of DSR 2.0
Sequana Medical NV has announced that the first patient has been enrolled in the MOJAVE study, a ran...
Alvimedica launches Kaplan curves radial portfolio for diagnostic procedures
Alvimedica has announced the launch of the Alvision Kaplan curves radial portfolio for diagnostic pr...
Streamlined TAVI pathway paves the way for same-day discharge “record”
Physicians at the James Cook University Hospital (Middlesbrough, UK) have performed ten transcat...
Researchers develop flexible bioresorbable monitor for cardiac patients
Researchers have developed a soft, fully bioresorbable, transparent microelectrode array (MEA) for m...
“World’s first” dual chamber leadless pacemaker system granted US FDA approval
Abbott has announced that the US Food and Drug Administration (FDA) has approved the Aveir dual cham...
Key messages from EBC MAIN at three years
EBC MAIN investigator David Hildick-Smith (Brighton, UK) delivers key messages from the trial’s ...
Medtronic heralds ESH guidelines as a “turning point” for renal denervation
In the wake of the release of update guidelines from the European Hypertension Society (ESH) guideli...
Combination of chronic kidney disease and diabetes associated with a higher rate of death or MI among women undergoing PCI
The combined presence of chronic kidney disease and diabetes among women undergoing percutaneous cor...
Minimum level of oxygen required during cardiopulmonary bypass “may be lower than previously thought”
Researchers have found that the minimum level of oxygen delivery during cardiopulmonary bypass may b...
Translumina acquires Blue Medical Devices
Translumina has announced the acquisition of Blue Medical Devices, a Wellinq group company, base...
ALL-RISE study of CathWorks FFRangio system enrols first patient
CathWorks has announced that the first patient has been enrolled in the Advancing cath lab resul...
Depressed ICD patients “more likely to stop medications”
Patients who feel low when having a cardiac device implanted are more likely to stop taking thei...
New arterial hypertension guidelines update recommendations on the use of renal denervation
New and expanded guidelines from the European Society of Hypertension (ESH) concerning the managemen...
ECG-AI algorithm for early identification of amyloidosis gains US FDA breakthrough designation
Anumana has received breakthrough device designation from the US Food and Drug Administration (FDA) ...
Vygon to manufacture vascular outflow tract for Aeson artificial heart
Vygon, a specialist in the design, manufacturing and marketing of medical devices, has signed an exc...
iTFlow blood flow analysis software gains US FDA approval
The US Food and Drug Administration (FDA) has approved the use of iTFlow in blood flow analysis.
...
CorWave closes series C funding round
CorWave has raised €61 million to fund its first industrial deployment and entry into clinical trial...
egnite and JenaValve partner to assess prevalence of aortic regurgitation in USA
egnite and JenaValve Technology have announced a strategic partnership aimed to offer insight on the...
Anxiety affects high proportion of patients with an ICD
Nearly one-third of patients with an implanted device to prevent sudden death have anxiety in th...
CHOP physicians conduct first-in-human implant of MASA polymeric pulmonary valve
PECA Labs has announced the successful first-in-human implant of the MASA valve, a polymeric valved ...
Pacing wire for TAVI and balloon aortic valvuloplasty procedures gains US FDA clearance
Teleflex has received US Food and Drug Administration (FDA) clearance for the Wattson temporary paci...
STEMI patients “lose years of life” due to care delays during COVID-19 lockdowns
Patients with ST-elevation myocardial infarction (STEMI) occurring during the first COVID-19 loc...
EuroPCR 2023: Biolimus-coated balloon fails to match paclitaxel for in-stent restenosis
Results of the first study of a first-generation drug-coated balloon (DCB) with a biolimus coati...
US FDA approval for AI TAVI planning software
Dasi Simulations has announced it has received US Food and Drug Administration (FDA) clearance for i...
ESC appoints Jean-François Riffaud as CEO
The European Society of Cardiology (ESC) has announced the appointment of Jean-François Riffaud ...
Translumina extends European reach with Lamed acquisition
Translumina has announced the acquisition of Munich-based Lamed GmbH, which the company says mov...
US FDA seeks to “modernise” clinical trials with new draft guidance
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendatio...
Research highlights “strikingly low” use of public defibrillators in cardiac arrest
Defibrillators are being used in just one in 10 cardiac arrests where they are available, according ...
Lars Søndergaard joins Abbott’s structural heart business
Lars Søndergaard has left his role as professor of cardiology at Rigshospitalet, Copenhagen Universi...
Conformal Medical completes series D financing round
Conformal Medical has announced the successful completion of its series D funding round, raising...
First TAVI procedures performed using F2 cerebral embolic filter
EnCompass Technologies has announced its novel F2 cerebral embolic filter was used successfully in t...
Amazon executive joins Medtronic to spearhead development in robotics and implantables
Medtronic has announced that Ken Washington has been appointed chief technology and innovation offic...
First-in-man implant of “modular” TAVI device performed in Israel
Valve Medical, a wholly owned subsidiary of Medinol Ltd, has announced the first-in-human (FIH) impl...
ADVERTORIAL: Keeping stroke at bay for patients undergoing TAVI
This advertorial is sponsored by Boston Scientific
Stroke—particularly disabling stroke—is among ...
MONITOR-HF trial results show improvement in quality of life scores for heart failure patients with CardioMEMS system
New data presented from an investigator-sponsored European trial found managing indicated heart fail...
Proprietary antioxidant complex shown to safeguard DNA from radiation exposure during aortic procedures
Cora Therapeutics has announced the presentation of the results of a clinical trial at the Canad...
SCAI 2023: Similar revascularisation rates seen with ticagrelor monotherapy and DAPT in TWILIGHT trial
Ticagrelor monotherapy after three months of ticagrelor plus aspirin was associated with similar...
HRS 2023: BIO-LIBRA study offers insights into device treatment of non-ischaemic cardiomyopathy
Preliminary results from the BIO-LIBRA study, assessing the outcomes of device-treated ventricul...
HRS 2023: SOLVE-CRT results “offer new hope for patients with hard-to-treat heart failure”
Results from a pivotal clinical trial found a leadless pacemaker can deliver cardiac resynchroni...
Ruggero De Paulis
Inventor of the Valsalva aortic graft Ruggero De Paulis (European Hospital Unicamillus University, R...
Cardiovascular News – Issue 69 – May 2023: US Edition
In this issue:
A new era for intracoronary imaging
Top trials from ACC 2023
Profile: Rugg...
TVT registry analysis finds close to 90% success in mitral TEER procedures
A large registry study of patients undergoing transcatheter edge-to-edge repair (TEER) for degen...
HRS 2023: Researchers hope to use AI to “revolutionise” prediction of sudden cardiac death
A novel artificial intelligence (AI) model correctly identified patients at near-term risk of sustai...
EuroPCR 2023: Global SYMPLICITY registry offers renal denervation insights out to three years
Analysis of the Global SYMPLICITY registry DEFINE (GSR DEFINE), presented at EuroPCR 2023 (16–19...
Finding the roots of the disease before treating it: Modelling NSTEMI
Paolo Contessotto (National University of Ireland Galway, Galway, Ireland) outlines his research dev...
SCAI 2023: No increased risk of hand dysfunction from distal compared to proximal radial artery access for cardiac procedures
A randomised controlled trial comparing the safety of distal versus proximal radial artery access fo...
SCAI 2023: Mechanical thrombectomy improves symptoms and quality of life in pulmonary embolism patients at six months
Six-month outcomes from FLASH registry have shown that patients with pulmonary embolism who were tre...
SCAI 2023: Two-year results “demonstrate strong clinical and haemodynamic outcomes” of Harmony transcatheter valve
Medtronic has announced two-year results for its Harmony transcatheter pulmonary valve (TPV) system,...
EuroPCR 2023: One-year BIOMAG-I results demonstrate safety and efficacy of resorbable scaffold platform
Results of the first-in-human study BIOMAG-I study, assessing Biotronik’s latest-generation Drea...
SCAI 2023: NACMI registry finds increased incidence of clotting among STEMI patients with COVID-19
Analysis from The North American COVID-19 STEMI (NACMI) registry, presented as late-breaking cli...
SCAI 2023: George Dangas begins term as SCAI president
The Society for Cardiovascular Angiography & Interventions (SCAI) has named George Dangas (I...
EuroPCR 2023: BIOADAPTOR trial shows non-inferiority of DynamX scaffold to DES for TLF at 12 months
Elixir Medical has announced that the BIOADAPTOR RCT trial of the company’s DynamX coronary drug...
EuroPCR 2023: Benchmark Registry data demonstrate improved TAVI efficiency
New data from the Benchmark Registry, a study of a streamlined transcatheter aortic valve implantati...
EuroPCR 2023: Carbon dioxide flushing prior to TAVI may offer protection against brain injury
A process of flushing prosthetic valves using carbon dioxide (CO2) prior to transcatheter aortic...
AATS 2023: COMMENCE aortic trial data shared through seven years
Edwards Lifesciences has announced new data from the COMMENCE aortic trial, demonstrating low ra...
EuroPCR 2023: Chimney stenting and BASILICA both seen to be effective in preventing TAVI-related coronary obstruction
A real-world comparison of two techniques aimed at reducing the risk of coronary obstruction aft...
EuroPCR 2023: Three-year EBC MAIN results demonstrate need for pragmatism in left main bifurcation stent strategy
Operators performing percutaneous coronary intervention (PCI) in bifurcation left main stem sten...
EuroPCR 2023: Imaging technology reduces contrast use during PCI
The use of an image-guidance system that overlays angiographic images on live fluoroscopic image...
Cardiovascular News – Issue 69 – May 2023: OUS Edition
In this issue:
A new era for intracoronary imaging
Top trials from ACC 2023
Profile: Rugg...
EuroPCR 2023: Robocath launches new robotic PCI platform
Robocath has announced the launch of its latest robotic platform—the R-One+.
The company is showc...
Shockwave Medical’s C2+ coronary IVL catheter launched in select markets
Shockwave Medical has announced the full commercial availability of the Shockwave C2+ coronary intra...
Foldax acquires proprietary polymer patent family
Foldax has announced that it has executed an agreement with Australia’s national science agency,...
SavvyWire to be assessed in COMPLETE TAVR substudy
OpSens has announced the inclusion of SavvyWire in the COMPLETE TAVR clinical study to investigate t...
Turning extra pulses into pluses
This educational supplement, sponsored by Shockwave Medical, gains fresh perspective on the manageme...
More shocks for rocks
How has the new Shockwave C2+ catheter changed the treatment of calcified coronary lesions at He...
Managing eccentric and nodular calcium with IVL
Calcified nodules are frequently identified among coronary artery lesions and are associated wit...
The r(evolution) of calcium in Bristol
Tom Johnson (University Hospitals Bristol & Weston NHS Foundation Trust, Bristol, UK) outlin...
ADVERTORIAL: Ongoing studies add to evolving understanding of TAVI valve durability
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New data offer greater perspective on the long-ter...
ADVERTORIAL: Ready for the primetime? The future role of drug-coated balloons in PCI
This advertorial is sponsored by B Braun Melsungen AG
“The evolution of PCI has always been a co...
US FDA expands indication for Farxiga
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the USA to reduce the risk of cardiovascu...
First patient treated in head to head trial of TAVI embolic protection devices
Emboline has announced that the first patient has been treated in the Protect the Head to Head inves...
Handheld ECG device scoops CX 2023 Innovation Showcase prize
Judges of the CX 2023 Dragon’s Den-style contest — the finale of the Day 3 CX Innovation Showcas...
Study highlights disparity in TAVI outcomes based on availability
Research has highlighted significant regional variations in the availability of transcatheter ao...
Ultromics’ AI platform for detecting cardiac amyloidosis gains FDA breakthrough status
Ultromics has been granted US Food and Drug Administration (FDA) breakthrough device status for its ...
Carillon mitral contour system gains EU MDR certification
Cardiac Dimensions has announced that its Carillon mitral contour system, for the treatment of f...
CAAS Qardia gains Japanese certification
Pie Medical Imaging has received NINSHO Medical Device Certification for CAAS Qardia, its echocardio...
First US implant of Lux-Valve Plus transcatheter tricuspid valve performed in Detroit
The first transcatheter tricuspid valve replacement procedure in the USA using the LuX-Valve Plu...
Shockwave Medical completes Neovasc acquisition
Shockwave Medical has announced the completion of its previously announced acquisition of Neovas...
OpSens completes European enrolment in SAFE-TAVI study
OpSens has announced the successful completion of enrolment in the SAFE–TAVI clinical study, studyin...
Cardiovascular News’ top 10 stories of March 2023
The news agenda in March was dominated by late-breaking data from the American College of Cardiology...
Research project to determine how stretching and blood flow impact engineered heart valves
New research will investigate how stretching and blood flow can inhibit or encourage cardiovascu...
Medtronic launches technology aimed at simplifying MRI screening for patients with implanted cardiac devices
Medtronic has announced the launch of MRI Care Pathway, a new system designed to streamline the proc...
PROACTIVE-HF pivotal trial completes enrolment
Endotronix has announced its PROACTIVE-HF pivotal study has successfully completed enrolment.
...
Smart glasses guide remote support for pioneering TAVI procedure
The UK’s first remotely-supported transcatheter aortic valve implantation (TAVI) using smart glasses...
Enrolment target met in ECLIPSE coronary atherectomy trial
Cardiovascular Systems has announced the complete enrolment of its 2,000-patient ECLIPSE coronar...
Experts update consensus on left atrial appendage closure
The Society for Cardiovascular Angiography & Interventions (SCAI) and the Heart Rhythm Socie...
Abbott’s Epic Max stented tissue aortic valve gains US FDA approval
Abbott has announced that the US Food and Drug Administration (FDA) has approved the company's E...
Azeem Latib joins Supira Medical as medical director
Supira Medical has announced the appointment of Azeem Latib (Montefiore Health Systems, New York...
ADVERTORIAL: “No stroke is innocent”: Why stroke matters for TAVI patients
This advertorial is sponsored by Boston Scientific
Today there are more than 75,000 transcatheter...
PADN-5 study results “exciting” for pulmonary artery denervation in heart failure and CpcPH patients
Results from the PADN-5 study, investigating the efficacy and safety of pulmonary artery denerva...
Enrolment reaches midway point in trial of Early Bird bleed monitoring system
Saranas has announced that it has reached the midpoint for enrolment in SAFE-MCS, a multicentre, sin...
Thousandth patient enrolled in SELUTION DeNovo coronary study
MedAlliance has announced enrolment of over 1,000 patients in its SELUTION DeNovo coronary randomise...
Immediate revascularisation non-inferior to staged procedure in acute coronary syndrome and multivessel disease
Immediate, complete revascularisation with percutaneous coronary intervention (PCI) in patients ...
Robotic electrophysiology programme opens in south eastern USA
Stereotaxis has announced the opening of a new robotic electrophysiology programme at Broward He...
BIOMAG-I study demonstrates low rate of in-scaffold late lumen loss at six months
Angiographic and clinical data from the BIOMAG-I clinical study, presented at the 2023 Cardiovas...
US FDA approval for Essenz heart-lung machine
LivaNova has announced the receipt of US Food and Drug Administration (FDA) 510(k) clearance for its...
ACC 2023: REVIVED-BCIS-2 results challenge “long-held beliefs” on myocardial viability testing prior to PCI
Assessing myocardial viability does not aid the selection of patients who will benefit—or not—fr...
Cardiovascular News’ top 10 stories of February 2023
February’s trending topics included a look at the past, present and future of transcatheter aortic v...
New data examine mortality rates and cardiac damage in early-stage aortic stenosis patients
Edwards Lifesciences has highlighted new data examining mortality rates and cardiac damage of ea...
EU ministers approve changes to MDR transition timetable
The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for ...
ACC 2023: Pulsed AF trial yields “promising” safety and efficacy results for PFA system
Results of the Pulsed AF Pivotal trial, investigating pulsed field ablation (PFA) treatment in p...
ACC 2023: Equivalent recovery times shown between minimally invasive and conventional surgery for mitral valve repair
The largest randomised controlled trial to date to compare minimally invasive and conventional c...
Neovasc shareholders approve acquisition by Shockwave Medical
Neovasc has announced that its shareholders have approved the previously-announced acquisition o...
ACC 2023: Intravascular imaging bests angiography guidance in trial of PCI in complex lesions
Use of intravascular imaging guidance for percutaneous coronary intervention (PCI) in patients with ...
ACC 2023: Large bore mechanical thrombectomy reduces adverse outcomes in high-risk PE patients
Large bore mechanical thrombectomy with the FlowTriever system (Inari Medical) in patients with ...
ACC 2023: MitraClip meets endpoints at five years in COAPT trial
Final, five-year clinical outcomes from the COAPT trial, evaluating transcatheter mitral valve r...
ACC 2023: Benefit of TAVI “consistent” over first three years in low risk patients
Three-year results from the Evolut Low Risk trial have shown “durable” benefits of transcatheter...
ACC 2023: Quality of life improvements drive benefit for transcatheter therapy in TRILUMINATE pivotal trial
Hotly-anticipated results of the randomised TRILUMINATE pivotal trial, presented during the 2023...
Preclinical model could aid future research of NSTEMI therapies
Researchers have detailed a new preclinical model for non-ST elevation myocardial infarction (NSTEMI...
HyperVue intracoronary imaging system gains US FDA approval
SpectraWAVE has announced US Food and Drug Administration (FDA) 510(k) clearance of its flagship int...
CRT 2023: Abbott shares new data on Navitor TAVI and Amplatzer Amulet LAAO systems
Results from the PORTICO NG study of Abbott’s Navitor transcatheter aortic valve implantation (TAVI)...
Five-year durability analysis of CoreValve and Evolut platforms “underscores long-term promise of TAVI”
Five-year bioprosthetic valve dysfunction data for Medtronic’s CoreValve and later-generation Ev...
Results of cell therapy trial in patients with heart failure due to low EF published in JACC
Results of a trial involving cell therapy in patients with chronic heart failure due to low ejec...
CONFORMAL EFS study results presented at CRT 2023
Results from the CONFORMAL early feasibility study (EFS), evaluating the use of angiography comp...
Risk model adds to prediction tools for surgical risk in adult congenital heart disease patients
A model designed to predict surgical risk in the setting of adult congenital heart disease (ACHD) im...
Medtronic welcomes ESC and EAPCI renal denervation consensus statement
Medtronic has welcomed the publication of the consensus statement on renal denervation issued by the...
First patient treated in A PRIORI pilot trial of Aortix circulatory support device
Procyrion has announced the successful treatment of the first patients in the A PRIORI—Aortix therap...
Medtronic relaunches Harmony transcatheter pulmonary valve
Medtronic has announced the relaunch of its Harmony transcatheter pulmonary valve (TPV) system, a mi...
Barostim misses primary endpoint in BEAT-HF postmarket trial
CVRx has announced the preliminary topline results of the BeAT-HF—Baroreflex activation therapy for ...
US FDA clears tool to rapidly analyse RV/LV ratio
RapidAI announced it has received US Food and Drug Administration (FDA) 510(k) clearance for Rapid R...
Renal denervation “can reach new shores”
The publication of a consensus statement from the European Society of Cardiology (ESC) Council o...
Teleflex grows catheter portfolio following US FDA approval
Teleflex Incorporated has today announced key milestones in the release of two new catheters, includ...
Xeltis secures funding to progress clinical trials
Xeltis has raised €32 million in a Series D2 equity fundraise, backed by a syndicate of current and ...
ACC, AHA and SCAI lay roadmap for interventional cardiology training
The American College of Cardiology (ACC), the American Heart Association (AHA) and the Society for C...
ESC and EAPCI publish renal denervation consensus statement
Renal denervation represents another treatment option in patients with uncontrolled resistant hypert...
COPS trial shows feasibility of using a cutting balloon at high pressure to modify calcium prior to PCI
Attendees of the 2023 Joint Interventional Meeting (JIM, 9–11 February, Milan, Italy) heard results ...
OPN NC “super-high-pressure” coronary balloon launches in USA
SIS Medical AG has announced the launch of its OPN NC percutaneous transluminal coronary angioplasty...
GE HealthCare to acquire AI ultrasound developer Caption Health
GE HealthCare has signed an agreement to acquire Caption Health, a developer of artificial intel...
ADVERTORIAL: DCB therapy offers a glimpse of interventional cardiology’s past and future
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“Everything started with balloon inflations in t...
Home-based therapy can help to reduce anxiety and depression in cardiovascular patients
A randomised study led by Greater Manchester Mental Health NHS Foundation Trust (GMMH) and the U...
Cardiovascular News 68 – February 2023: US Edition
In this issue:
Medicare study reopens guideline debate around surgery and PCI in patients with ...
Cardiovascular News 68 – February 2023: OUS Edition
In this issue:
Medicare study reopens guideline debate around surgery and PCI in patients with ...
ADVERTORIAL: A step forward in scoring balloon catheter design
This advertorial is sponsored by iVascular
A new coronary scoring balloon dilatation catheter...
Automated alert tool “associated with a small decrease in contrast use” during PCI
Performance improvement company Biome Analytics has announced the publication of a study in Circulat...
TruLeaf Medical to trial “two-stage” TMVR platform
TruLeaf Medical is to conduct a first-in-human clinical trial of a “two-stage” transcatheter mit...
PCI can be performed as safely without on-site access to surgery, says SCAI
Percutaneous coronary intervention (PCI) without on-site surgical support is as safe as PCI at centr...
Cardiovascular-aortic community comes together at CX 2023
From cutting-edge aortic interventions to consensus on revascularisation strategies in the periphera...
ADVERTORIAL: A wealth of data underscore treatment choices for coronary DCBs
This advertorial is sponsored by B. Braun Melsungen AG
The modern field of percutaneous coron...
First patient treated in LeAAPS trial of left atrial appendage occlusion in cardiac surgery patients
AtriCure has announced that the first patient was treated in the LeAAPS clinical trial, a prospectiv...
Slow progress made on gender balance in cardiovascular trial leadership
Little progress has been made over the last decade in improving gender balance in leadership positio...
Nieves Gonzalo
Interventional cardiology is a rapidly evolving field, offering the opportunity to learn procedures ...
Medicare study reopens guideline debate around surgery and PCI in patients with multivessel coronary artery disease
An analysis of data from more than 100,000 patients with multivessel coronary artery disease und...
First US patient enrolled into study of Selution SLR coronary drug-eluting balloon
The first US patient has been enrolled at Medstar Washington Hospital Center (Washington DC, USA) in...
STS 2023: Risk assessment tool “sets a high bar” when considering alternatives to surgery in mitral valve repair
A new risk assessment tool has been produced to provide a comprehensive method for assessing ope...
Enrolment milestone reached in trial of angiography-based vessel fractional flow reserve in coronary revascularisation
Pie Medical Imaging has announced the enrolment of the 500th patient in the FAST III clinical trial,...
Trial of super saturated oxygen therapy after PCI begins enrolment
Zoll has announced that the first patient has been enrolled in the REAL SSO2 post-market observation...
Registry data point to a declining rate of complications among primary MR patients
The largest dedicated registry on mitral transcatheter edge-to-edge repair (M-TEER) in primary m...
Shockwave agrees to acquire Neovasc
Shockwave Medical has entered into a definitive agreement to acquire Neovasc Inc, developer of t...
US FDA approves use of Navitor TAVI valve in high-risk aortic stenosis patients
The US Food and Drug Administration (FDA) has approved the Navitor (Abbott) transcatheter aortic val...
Effects of short DAPT “consistent regardless of high bleeding risk and complex PCI”
Research evaluating the effects of high bleeding risk (HBR) and complex percutaneous coronary interv...
Pie Medical Imaging announces launch of CAAS Qardia 2.0 echocardiography software platform
Pie Medical Imaging has launched a new version of its echocardiography software platform—CAAS Qardia...
NICE lowers threshold for statins to prevent cardiovascular events
The UK’s National Institute for Health and Care Excellence (NICE) has published draft guidance recom...
HVR Cardio closes €10.7 million series B funding round
HVR Cardio has closed on a €10.7 million series B round of financing. The Series B Round was led...
Depression increases likelihood of non-adherence to medical therapy post-PCI
Patients with depression were 10–20% less likely to adhere to guideline-directed medical therapy aft...
Multidisciplinary teams at the heart of new guidelines on aortic disease management
Closer ties between cardiologists, cardiac surgeons and vascular surgeons will be a hallmark of the ...
MedAlliance’s Selution SLR receives coronary de novo IDE approval
Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, has received conditional US Food and Dr...
Preclinical study outlines key features of foam-based LAA closure device
A preclinical study demonstrating key features of the foam-based left atrial appendage closure d...
Cardiac Dimensions closes funding round to support US EMPOWER pivotal study
Cardiac Dimensions has closed a US$35 million Series D financing round. The financing was co-led...
Funding secured to advance development of Pulse IVL system
AVS has announced that it raised US$20 million in Series B financing, which the company says will ac...
Cardiovascular News’ top stories of 2022
Which stories, features and interviews captured the attention of the cardiovascular community across...
SCAI announces recipients of early career grant scheme
The Society for Cardiovascular Angiography & Interventions (SCAI) has announced the four recipie...
No sex difference seen in outcomes for transcatheter tricuspid valve intervention
Transcatheter tricuspid valve intervention is associated with similar outcomes in both women and...
ReCor appoints Lara Barghout to lead commercialisation of Paradise renal denervation system
ReCor Medical and its parent company Otsuka Medical Devices have announced the appointment of La...
Enrolment begins in trial to assess new therapy in patients deemed unsuitable for anticoagulants
Anthos Therapeutics has announced that it has enrolled the first patient in LILAC-TIMI 76, a pha...
Johnson & Johnson completes Abiomed acquisition
Johnson & Johnson has today announced it has completed its acquisition of Abiomed. Abiomed is no...
Machine learning enables “clinically important” characterisation of coronary artery disease
Using machine learning and clinical data from electronic health records, researchers have constructe...
Stem cell plasters “could revolutionise treatment of congenital heart disease”
Researchers have developed ‘stem cell plasters’ which it is hoped will revolutionise the way sur...
Enrolment begins in Impella ECP pivotal trial after US FDA green light
The first two patients have been enrolled in the Impella ECP pivotal trial, after the US Food an...
STAR-T trial of antithrombotic removal system during cardiac surgery to continue
CytoSorbents Corporation has received the recommendation from the independent Data and Safety Mo...
First US procedure performed using ShortCut leaflet splitting device
Pi-Cardia has announced that the first patient in the USA has been successfully treated with ShortCu...
Cardiology societies urge rethink of randomised controlled trial design
The current model for randomised clinical trials must be redesigned for the modern age, according to...
Pilot study of wire pacing sleeve yields positive results in TAVI and PCI procedures
A first-in-human trial using a purpose-built device to provide direct wire pacing without the need f...
Corindus rebrands to Siemens Healthineers Endovascular Robotics
Corindus has been rebranded to Siemens Healthineers Endovascular Robotics and will sit as a dedi...
EU Commission to propose delay to MDR implementation
Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the tran...
UK regulator approves dapagliflozin for use in heart failure across the full spectrum of left ventricular ejection fraction
AstraZeneca has today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) ...
TRICares secures financing to fund development of Topaz tricuspid valve replacement system
TRiCares has announce the second closing and completion of its Series C financing round, successfull...
First patient randomised in RESPONDER-HF trial of Corvia atrial shunt
Corvia Medical has announced that the first patient has been randomised in RESPONDER-HF, a globa...
ESC warns of cardiac device shortage due to implementation of MDR regulations in Europe
The European Society of Cardiology (ESC) has urged European Union (EU) health ministers to act to pr...
Postmarket data point to lower rates of PVL with Acurate neo2 TAVI valve
The addition of an annular sealing skirt, among other design changes in the Acurate neo2 transca...
TRISCEND trial reports one-year outcomes in patients undergoing transcatheter tricuspid valve implantation
One-year results from the TRISCEND study, investigating the Evoque (Edwards Lifesciences) tricus...
ADVERTORIAL: TAVI valve durability and reliability: How patient lifetime management is evolving
This advertorial is sponsored by Medtronic
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DurAVR heart valve system gets green light from US FDA for early feasibility study
Anteris Technologies has announced that the US Food and Drug Administration (FDA) has conditionally ...
First implant of MonarQ tricuspid valve replacement system performed in Copenhagen
inQB8 Medical Technologies, in partnership with Peijia Medical, has announced first successful i...
Nyra Medical secures investment for transcatheter mitral valve repair technology
Nyra Medical has announced the closing of a US$20 million Series A financing.
The round was c...
First-in-human procedure performed using Impella RP Flex
The first implant procedure using the Impella RP Flex (Abiomed) percutaneous pump, following its rec...
Late-breaking Xlimit randomised trial data shared at CSC 2022 congress
Data presented at an innovation session at the 2022 Structural and Coronary Intervention Course (CS...
Timothy D Henry
A pioneer of one of the first regional ST-segment elevation myocardial infarction (STEMI) systems in...
Carmat resumes commercial implants of Aeson artificial heart
Carmat has announced the resumption of commercial implants of its Aeson total artificial heart.
C...
CroíValve reports successful first in human implants of its Duo tricuspid coaptation valve system
CroíValve has announced the successful first in human implants of its Duo tricuspid coaptation v...
Cardiovascular News 67 – November 2022: OUS Edition
In this issue:
Latest evidence from key renal denervation trials
REVIVED-BCIS 2: PCI fails t...
Cardiovascular News 67 – November 2022: US Edition
In this issue:
Latest evidence from key renal denervation trials
REVIVED-BCIS 2: PCI fails t...
Rates of all-cause death align between invasive and conservative strategies in ISCHEMIA-EXTEND
Extended follow-up of the ISCHEMIA-EXTEND trial has shown no difference in rates of all-cause mo...
AI system to aid decision making for aortic aneurysm treatment
Viz.ai has announced a partnership with Illuminate, a developer of proprietary natural language proc...
Use of clinical support platform “reduces risk of kidney injury” from PCI
Patients at high risk for acute kidney injury (AKI), the most common complication of percutaneous co...
RELIEF clinical study to assess use of Cardioform septal occluder for migraine relief
WL Gore & Associates has announced that it is initiating the RELIEF clinical study—an invest...
Neovasc Reducer assigned outpatient reimbursement code from CMS
Neovasc has announced that the Centers for Medicare and Medicaid Services (CMS) has assigned the Neo...
New surgical thresholds and need for multidisciplinary teams reflected in revised aortic guidelines
The American College of Cardiology (ACC) and American Heart Association (AHA) have jointly published...
Johnson & Johnson reaches agreement to acquire Abiomed
Johnson & Johnson is to acquire Abiomed, it was announced today, after the two organisations ent...
Impella RP Flex with SmartAssist receives US FDA approval to treat right heart failure
Abiomed has announced that Impella RP Flex with SmartAssist has received US Food and Drug Administra...
Carmat gains approval to resume clinical study of total artificial heart
Carmat, developer of the Aeson total artificial heart, has announced that it has been granted th...
US FDA accepts post-approval study reports for Impella
Abiomed has announced the US Food and Drug Administration (FDA) has accepted and closed the post...
First patients treated in SAFE-TAVI clinical study
OpSens Medical has announced the successful completion of the first cases in a clinical study—SAFE-T...
Selution SLR receives US FDA investigational device exemption approval for coronary clinical trial
Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, has received US Food and Drug Administr...
Ticagrelor after CABG associated with a decreased risk of vein graft failure compared to aspirin
In patients undergoing coronary artery bypass graft (CABG) surgery, the addition of ticagrelor t...
LeAAPS trial to explore benefit of left atrial appendage occlusion in cardiac surgery patients at risk for stroke
Researchers are to investigate the safety and efficacy of performing left atrial appendage occlu...
AccurKardia and Mawi link up to add automated ECG analytics for the new Mawi Watch
AccurKardia, a software company that provides clinical-grade, device agnostic, automated electrocard...
HeartFlow receives US FDA approval for Plaque and RoadMap analysis AI products
HeartFlow has received US Food and Drug Administration (FDA) 510(k) clearance on two new, AI-pow...
MedAlliance to be acquired by Cordis
MedAlliance is to be acquired by Cordis, it was announced today, after the two companies reached agr...
Rates of stroke and embolism lower with apixaban compared to rivaroxaban
In a large, population-based study of patients with atrial fibrillation (AF) and valvular heart dise...
Abiomed gains FDA approval for Impella low profile sheath
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed to market a ne...
Swedish registry data point to survival benefit for younger patients undergoing CABG
An analysis of data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) has s...
Analysis shows survival benefit in high-risk PCI supported by Impella
An analysis of more than 2,000 patients from a large US real-world database finds that patients ...
Swedish and Dutch organisations agree to research collaboration
The Uppsala Clinical Research Center (UCR) and the European Cardiovascular Research Institute (E...
Minimally invasive aortic perfusion cannula receives EACTS Techno-College innovation award
The developers of a cannula for minimally-invasive central aortic perfusion—MIC-Cannula—received...
CathWorks gains Japanese regulatory approval for FFRangio system
CathWorks has announced approval of the fourth generation CathWorks FFRangio system by the Japan...
EACTS 2022: Global studies will fill gap for “high-quality evidence” on invasive treatment of ischaemic cardiomyopathy
A global research initiative will compare coronary artery bypass graft surgery (CABG) and percut...
EACTS 2022: “Wake up call” for trialists over gender balance
Clinical trials in cardiothoracic surgery must ensure that sufficient numbers of women are enrol...
Latest data underscore optimism for future of renal denervation
Ajay Kirtane (Columbia University Irving Medical Center New York-Presbyterian Hospital, New York...
Long-term P2Y12 monotherapy after PCI “may be a promising strategy”
Three-year outcomes from the SMART-CHOICE trial have shown that P2Y12 inhibitor monotherapy was asso...
Enrolment completed in trial comparing PCI in diabetic patients
ABILITY DIABETES-GLOBAL, a randomised controlled head-to-head trial comparing safety and efficacy of...
Puzzle Medical wins 2022 TCT Shark Tank innovation competition
Puzzle Medical Devices was announced as the winner of the Shark Tank innovation competition at the 2...
Rivaroxaban may be an option for reducing radial artery occlusion in transradial coronary procedures
The use of rivaroxaban for seven days after a transradial coronary procedure reduced the rate of...
Unloading with Impella for 30 minutes prior to PCI linked to reduced infarct size in STEMI patients
Results of a new per-protocol analysis of the ST-segment Elevation Myocardial Infarction Door-To...
First US TAVI procedure performed using SavvyWire guidewire
OpSens has announced that Philippe Genereux (Morristown Medical Center, Morristown, USA) has perform...
Data from BIOSOLVE-IV and BIOMAG-I trials shared at TCT 2022
Biotronik has announced the presentation of new full-cohort two-year BIOSOLVE-IV data. In a post...
FDA approves Onyx Frontier and Resolute Onyx stents for bifurcation PCI
Medtronic has received Food and Drug Administration (FDA) approval for the treatment of non-left mai...
Clinical trial of TAVI in severe aortic regurgitation completes enrolment
JenaValve Technology has announced the successful completion of patient enrolment in the ALIGN-AR Pi...
TCT 2022: TEER in cardiogenic shock patients shows promise for lowering mortality and heart failure hospitalisation
Analysis of data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) ...
TCT 2022: UNIVERSAL trial finds ultrasound did not reduce vascular complications during femoral access for cardiac procedures
Results from a multicentre randomised trial comparing ultrasound with fluoroscopic guidance vers...
Medtronic expands US rollout of Evolut FX TAVI system
Medtronic has announced the expanded US market release of its newest-generation, self-expanding tran...
Shockwave initiates all female coronary IVL registry study
Shockwave Medical has initiated a prospective coronary intervention study consisting of all female p...
Breakthrough device designation granted for SirPlux Duo coronary DCB in small vessels
Advanced NanoTherapies has been granted US Food and Drug Administration (FDA) breakthrough devic...
TCT 2022: Amulet occluder keeps pace with Watchman at three years
Long-term follow-up of patients with non-valvular atrial fibrillation (AF) receiving the Amplatz...
TCT 2022 hears “important data” from renal denervation trials
Findings from the RADIANCE II randomised pivotal trial, presented at the 2022 Transcatheter Card...
TCT 2022: Valentin Fuster receives career achievement award
The major contribution of Valentin Fuster (Mount Sinai Health System, New York, USA) to the fiel...
TCT 2022: Pascal non-inferior to MitraClip in head-to-head trial in degenerative MR patients
The first randomised trial to compare two transcatheter edge-to-edge repair (TEER) devices —CLAS...
TCT 2022: No difference in rates of post-TAVI stroke seen with cerebral embolic protection device in PROTECTED TAVR
Among patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) the use of...
US FDA grants 510(k) clearance for SavvyWire TAVI guidewire
OpSens has received 510(k) regulatory clearance from the US Food & Drug Administration (FDA) for...
Precision medicine and upstream interventions in focus at TCT 2022 curtain raiser
The 2022 Transcatheter Cardiovascular Therapeutics (TCT, 16–19 September, Boston, USA) opened wi...
Abiomed given green light for RECOVER IV randomised trial
Abiomed has announced two approvals from the US Food and Drug Administration (FDA) related to clinic...
Cardiac Implants announces successful adjustment procedure using its Tri-Ring device to treat TR
Cardiac Implants has announced the successful initial deployment of its annuloplasty ring with imple...
Enrolment completed in TRANSFORM 1 trial of MagicTouch DCB
Concept Medical has announced the successful completion of the TRANSFORM 1 RCT. The randomised c...
TAVI costs comparable to surgery in low-risk patients, Canadian researchers conclude
A budget impact analysis comparing transcatheter aortic valve implantation (TAVI) with surgical ...
Vascade vascular and venous closure devices gain CE mark
Haemonetics Corporation has received CE mark certification for its Vascade vascular closure and ...
Latest Sapien TAVI valve features anti-calcification technology
Edwards Lifesciences has announced the launch of the Sapien 3 Ultra Resilia valve—combining Edwards’...
Three-year data “reinforce safety and efficacy” of Abbott’s Amplatzer Piccolo in infants with PDA
Abbott has announced three-year data for its Amplatzer Piccolo occluder for the treatment of patent ...
The time for change is now: Call for action over “ageing and unbalanced” cardiothoracic surgery community
Analysis of the global make-up of the four largest global societies for cardiothoracic surgery sugge...
Results of cuffless blood pressure monitor presented at AHA Hypertension Sessions
Results of an analysis of Aktiia’s cuffless blood pressure (BP) monitoring system are being presente...
First patient joins study of SSO2 therapy post-PCI
Zoll Medical has announced that the first patient has been enrolled in the AMIHOT III post-approval ...
Abbott’s Amplatzer Talisman PFO occlusion system launched in Europe
Abbott has announced the European launch of its Amplatzer Talisman patent foramen ovale (PFO) occlus...
AtriAN initiates second trial of pulsed field ablation in cardiothoracic surgery patients with paroxysmal AF
AtriAN Medical has announced that it has completed enrolment of a second study using its selective p...
Tom Nguyen
As a proponent of minimally invasive cardiac surgery and transcatheter techniques, Tom Nguyen (Unive...
Cardiovascular News’ top 10 most popular stories of August 2022
The most read stories from across Cardiovascular News in August 2022 include highlights from the Eur...
FDA clears Viz.ai’s right-to-left ventricle ratio algorithm
Viz.ai has received US Food and Drug Administration (FDA) 510(k) clearance for an automated right ve...
Latest centre begins using Philips’ Verisight Pro 3D intracardiac echocardiography catheter
Royal Philips has announced that Baptist Health’s Miami Cardiac & Vascular Institute (Miami, USA...
New DAPT labelling approved for Watchman FLX device
Boston Scientific has received US Food and Drug Administration (FDA) approval to expand the inst...
First patient enrolled in Hyper II study evaluating hybrid approach in long diffuse CAD
Cardionovum has announced the enrolment of the first patient in the international Hyper II clini...
JenaValve raises US$100 Million to advance Trilogy TAVI system
JenaValve Technology has announced that it has completed the initial closing of a US$100 million Ser...
ESC 2022: Risk score predicts mortality for AF patients after TAVI
Researchers have developed a risk score to predict mortality for patients with atrial fibrillati...
ESC 2022: Survival benefit seen following use of Abbott’s HeartMate 3 LVAD
Abbott has announced the release of late-breaking showing that its HeartMate 3 heart pump extend...
ESC 2022: Transradial access is “gold standard” approach for percutaneous coronary procedures
Transradial access for percutaneous coronary procedures is associated with lower rates of all-ca...
ESC 2022: MASTER DAPT continues to show merit for shortened dual antiplatelet therapy out to 15 months post-PCI
Fifteen-month results from the MASTER DAPT trial have shown that the preserved ischaemic benefit...
ESC 2022: Kidney disease patients with coronary disease see no improvement in survival at five years with an invasive approach
In patients with advanced chronic kidney disease (CKD) and chronic coronary disease, an invasive...
ESC 2022: FRAME-AMI sheds light on best strategy for selecting non-infarct lesions for PCI
Selection of non-infarct related artery (IRA) lesions for intervention using fractional flow res...
ESC 2022: High-risk aortic stenosis could be picked up using AI
Late-breaking research presented at the European Society of Cardiology (ESC) annual congress (26...
ESC 2022: POST-PCI trial finds no benefit to routine functional testing in high-risk PCI patients
Among high-risk patients undergoing percutaneous coronary intervention (PCI), a follow-up strate...
ESC 2022: AI outshines sonographer echocardiogram assessment in EchoNet-RCT
Results of one of the first and only randomised, blinded trials to assess the use of an artifici...
ESC 2022: REVIVED data show PCI does not benefit patients with severe left ventricular dysfunction
Percutaneous coronary intervention (PCI) does not reduce all-cause mortality or heart failure ho...
ESC 2022: SECURE trial finds “polypill” results in lower risk of cardiovascular events compared to usual care
Use of a ‘polypill’ after myocardial infarction (MI)—an all-in-one pill containing an antiplatel...
ESC 2022: Timing of antihypertensive medication “makes no difference” to cardiovascular outcomes
The timing of dosing of antihypertensive medication—whether it is taken in the morning or in the...
Programme released for TCT MedTech Innovation Forum
The Cardiovascular Research Foundation (CRF) and Fogarty Innovation have announced the programme...
Medtronic launches Onyx Frontier coronary stent following CE mark approval
Medtronic has announced the launch of its latest generation drug-eluting coronary stent—Onyx Frontie...
Cardiovascular News 66 – August 2022: OUS Edition
In this issue:
Call for action over age and gender profile of global cardiothoracic surgery com...
Cardiovascular News 66 – August 2022: US Edition
In this issue:
Call for action over age and gender profile of global cardiothoracic surgery com...
Miracor’s PiCSO technology approved by FDA for investigational device exemption study
Miracor Medical has announced the approval of an investigational device exemption (IDE) from the...
First-in-human procedure completed using ShortCut Mitral device
Pi-Cardia has announced a successful first-in-human treatment of the mitral valve with the ShortCut ...
Edwards gains CE mark for Pascal Precision system for mitral and tricuspid regurgitation
Edwards Lifesciences has announced that the company's Pascal Precision transcatheter valve repai...
Restore EF study “shows heart function, symptom improvements” for high-risk PCI patients supported by Impella
Abiomed has announced the results of the Restore EF study, demonstrating that Impella-supported hig...
CX Aortic Vienna: Cardiac and vascular surgeons collaborate at the vanguard of aortic care
CX Aortic Vienna returns in October for its third edition (24–26 October, Digital), bringing togethe...
AHA and CRF announce collaborative education programme
The American Heart Association (Association) and the Cardiovascular Research Foundation (CRF) have a...
Spotlight turns to TAVI in patients with moderate aortic stenosis
Ongoing clinical trials looking at transcatheter aortic valve implantation (TAVI) for patients w...
Cardiovascular News’ top 10 most popular stories of July 2022
The most read stories from across Cardiovascular News in July 2022 include reflections on the future...
“Worrisome” rise in cardiovascular disease predicted out to 2060
Projected rates of cardiovascular risk factors and disease will increase significantly in the USA by...
