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    Latest News

    CRT 2026: Late-breaking data highlight growing adoption of angiography-derived fractional flow reserve

    Valcare Medical strengthens board with dual appointment

    Mitria Medical’s Subvalvular Spacer implanted under compassionate use

    First ACC/AHA acute PE guidelines provide “roadmap” for management

    THT 2026: HFrEF patients undergoing baroreflex activation therapy see shift in LVEF

    Mike Buck joins TTVR developer VDyne as CEO

    THT 2026: Autologous cell therapy may curb pathological ventricular remodelling in chronic ischaemic HFrEF patients

    THT 2026: Study of smart implant for heart failure decongestion reports first-in-human data

    Evolut Low Risk investigators probe increasing reintervention rate beyond six years

    Abbott’s next-generation PA pressure reader gains US FDA approval

    Paradise renal denervation system available in Japan

    US FDA approves CT angiography system for visualising cardiac conduction system

    EAPCI Summit: Registry seeks to bridge ACS gender gap

    heart attacks

    EAPCI Summit: Serbian registry offers new insight on spontaneous coronary artery dissection

    Symplicity Spyral renal denervation system gains reimbursement approval in Japan

    EAPCI Summit: Rise in primary PCIs has not shifted the dial on acute MI mortality

    EAPCI Summit: One in five patients can be discharged on day of TAVI procedure

    Elumn8 Medical, formerly Simpson Interventions, closes financing round

    Cardiovascular intelligence software platform gains US FDA clearance

    PERTs improve outcomes but “magic formula” does not exist, LINC audience hears

    CRF to launch Complex Coronary Summit in 2027

    heart attacks

    PICCOLETO IV trial investigating SAPT after DCB-PCI in high-risk population launches

    AI-based ECG technology may improve aortic stenosis mortality prediction

    GAMEFILM registry expands to include retired NBA and NHL athletes

    First case of transcatheter mitral annuloplasty performed in AMEND EFS trial

    Next-generation contrast management system gets European market launch

    Funding secured to advance clinical programme for implantable heart failure device

    Peijia Medical seeks EU MDR approval for GeminiOne TEER system

    Statins likely not the cause of most side effects listed on packaging leaflets

    Off-pump CABG, in experienced hands, reduces perioperative complications with similar long-term survival

    STS data suggest surgeons have begun to shift the tide in TAVI explant mortality

    TricValve bicaval valve system gains EU MDR certification

    Investigator-led initiative supporting PE research launched

    UK’s NICE recommends implantable device for remote heart failure monitoring

    Jupiter Endovascular completes enrolment in SPIRARE II pivotal trial

    CADScor system achieves EU MDR certification

    TRIOMPHE

    Endospan announces one-year data from TRIOMPHE IDE study

    STS 2026: Long-term comparison of multi-arterial CABG strategies finds similar survival rates

    Medtronic exercises its option to acquire CathWorks

    GE HealthCare’s Allia Moveo gains FDA and CE mark approvals

    Badhwar elected STS president with focus on “excellence, evidence and impact”

    STS and ACC partner on new cardiac certification scheme

    First usage of ultrasound system to detect brain emboli in PFO patients

    Robocath launches FIH clinical study of second-generation robotic system in coronary artery disease

    Da Vinci 5 surgical robot gains new clearances for cardiac procedures

    CVRx announces initiation of BENEFIT-HF trial of Barostim device in “significantly expanded population”

    Study validates AI tool’s ability to detect valvular disease and ventricular dysfunction

    Evolocumab cuts MACE risk, even in patients with no prior events

    HighLife TMVR system gains CE mark

    Medtronic invests in Anteris Technologies, maker of DurAVR system

    First-in-man VECTOR procedure offers new approach for preventing coronary obstruction

    Trisol shares early results of TTVR system in severe to torrential TR

    Trial of polymer-free DES in STEMI PCI enrols first patients

    Extreme temperature

    Societies urge action on environmental stressors contributing to cardiovascular disease deaths

    TRiCares secures EIB loan to support clinical study of Topaz TTVR system

    Boston Scientific announces agreement to acquire Penumbra

    Conavi Medical secures funds to advance next-generation intravascular imaging platform

    coronary artery bypass

    Bypass surgery may offer longer-term benefit to women with severe coronary disease compared to PCI

    YorLabs’s intracardiac imaging system used for first time following US FDA clearance

    Gene therapy trial seeks to reduce coronary graft failure

    Edwards drops JenaValve acquisition after FTC injunction upheld

    Haemonetics acquires vessel closure specialist Vivasure Medical

    Marshall Mohr joins board at Capstan Medical

    Study shows predictor of adverse events after valvular interventions

    Robotic surgical system adds 5mm instruments for use in small structures

    Sonico-CX coronary IVL system gains CE mark

    Gore enters into agreement for acquisition of Conformal Medical

    Transseptal TMVR system gains US FDA approval

    Non-invasive screening system “actively detects elevated LV end-diastolic pressure”

    Relief Cardiovascular appoints former Endotronix CEO as chairman

    Delivery system for PDA closure in premature infants gains regulatory approvals

    OpusOne pVAD enters first-in-human study

    First-in-human trial of regenerative coronary bypass graft to commence

    AI platform identifies “critical mass” threshold of non-obstructive plaque in coronary artery disease

    Philips to acquire SpectraWAVE

    US FDA clears pivotal trial for bicaval valve system for TR

    Feasibility trial shows promising results for renal assist device

    Dedicated TAVI system for AR gains NMPA approval in China

    Coronary thrombectomy system gains US FDA clearance

    Aquapass fluid overload management system gains marketing approval in Israel

    EACVI: Study sheds light on prevalence of valvular heart disease amongst cancer patients

    Analysis shows predictive value of FFR-CT for cardiovascular events in angina patients

    RoseDoc system gets first-in-human use in tricuspid valve replacement cases

    Premarket notification submitted to FDA for SSi Mantra surgical robotic system

    Tenecteplase non-inferior to alteplase in thrombolytic success for valve thrombosis

    Non-invasive ultrasound therapy for aortic stenosis gains CE mark

    US FDA clearance for Hotwire transseptal access system

    AltaValve early feasibility study reports out to one year

    Hypertension drug baxdrostat accepted for priority review by US FDA

    “Durable” valve performance seen with early generation transapical TMVR system

    Largest dataset from ALIGN-AR trial shows favourable outcomes with Trilogy valve

    Procyrion appoints Andrew Davis to lead therapy development

    VisCardia secures funding to support RECOVER-HF trial

    New imaging tool launched to aid coronary interventions

    Akura Medical closes series C financing

    RSNA 2025: Abdominal obesity associated with harmful changes in heart structure

    Siemens Healthineers launches AI-powered imaging system, Optiq AI

    Latest data from Dragonfly pivotal studies shared at PCR London Valves

    Investment to accelerate development of VenstraMedical’s pVAD system

    US FDA clears TELLTALE TAVI guidewire system

    “We need to look at the totality of evidence”: VIVA panellists examine SWEDEPAD findings

    Vascular complications uncommon in study of latest-generation arterial closure device

    Music therapy improves patient experience during PCI and shows promise for fine tuning cardiovascular parameters

    Philips previews AI-powered guidance system for mitral TEER procedures

    PARADIGM trial of DurAVR TAVI valve gets US FDA green light

    Trilogy TAVI valve reaches 1,000 commercial cases

    First clinical procedures performed using AI TAVI guidance software

    CryoTherapeutics, SpectraWAVE and CRF partner for ICECAP clinical study

    Librexia ACS trial of factor Xia inhibitor in ACS patients ended early

    PCR London Valves 2025 hears latest data from LANDMARK trial of Myval TAVI device

    Poll highlights rising concern for radiation exposure among interventionists

    Cost analysis suggests benefit of early TAVI in asymptomatic aortic stenosis

    Low rates of PPM seen following TAVI in small aortic annuli with DurAVR system

    TARGET study demonstrates TR reduction with Cardiovalve system

    FAME 3: PCI shown to be more cost effective than CABG

    LAA closure fails to achieve non-inferiority versus standard care in AF patients with high stroke and bleeding risks

    AHA 2025: Ataciguat slows progression of aortic valve calcification

    New data point to predictive value of plaque volume for long-term events in coronary artery disease patients

    AHA 2025: Polypill shown to be effective in HFrEF patients

    AHA 2025: PCKS9 inhibitor use reduced LDL levels after heart transplant surgery

    Native vessel PCI “no longer the default strategy” for patients with previous CABG

    Alteplase fails to impact outcomes in STEMI patients with high thrombus burden

    Tendyne system shows promise in patients with mitral annular calcification

    Study of laser IVL system completes enrolment

    Transseptal TMVR system shows promise in patients unsuited for surgery or TEER

    Latest data “reassuring” on safety and effectiveness of transcatheter tricuspid interventions

    Virtue trial of sirolimus-eluting balloon enrols first patients

    AI helps smartwatch ECG sensors to detect structural heart disease

    AtriCure announces treatment of first patient in BoxX-NoAF clinical trial

    CMS finalises coverage decision for renal denervation systems

    Terumo announces US FDA clearance for OpusWave imaging system

    Interim RAPID-PE study reveals ‘excellent’ safety data in first 50 patients

    TCT 2025: Deferring treatment of non-culprit lesions “remains an option” for STEMI in multivessel disease

    Semaglutide prevents cardiovascular events regardless of weight loss

    TCT 2025: Coronary bioadaptor shows reduction in events compared to DES at two years

    TCT 2025: TAVI continues to match up to surgery at seven years in PARTNER 3 trial

    TCT 2025: “Site-less” trial opens window on prevalence of heart valve disease across USA

    TCT 2025: STORM-PE finds mechanical thrombectomy superior to anticoagulation alone

    TCT 2025: Trials find comparable outcomes for IVL alternatives in calcified coronary disease

    TCT 2025: Three-year results demonstrate “durable” impact of radiofrequency renal denervation

    TCT 2025: Selution SLR meets non-inferiority in de novo and in-stent restenosis trials

    Smart implant for pressure-guided heart failure decongestion wins TCT 2025 Shark Tank prize

    Protaryx Medical submits premarket notification to US FDA for transseptal puncture device

    Medtronic launches “extra stiff” TAVI guidewire

    TCT 2025 live blog

    Sustained remodelling achieved at two years with AccuCinch LV restoration system

    Study to compare non-invasive HF monitoring system with implant

    First-in-human study of Cardiac Leaflet Enhancer reaches enrolment milestone

    Medtronic partners with DASI Simulations to bring AI modelling technology to US TAVI centres

    AI algorithm for MAC detection and quantification gains US FDA approval

    Intensive cholesterol lowering fails to shift the dial on vein graft failure

    Pivotal trial of tricuspid annuloplasty system to commence following IDE approval

    Light-reactive technology offers promise for preventing vein graft failure

    Up to half of patients may experience AF after coronary surgery, but burden is low

    Enrolment completed in CONFORM pivotal trial of LAAO system

    EACTS 2025 hears new data on aortic arch remodelling device

    Medtronic’s Endurant receives US FDA labelling approval to remove rAAA treatment warning

    Dapagliflozin does not add to quality-of-life benefit gained from TAVI

    “Abbey Bear” seeks to demystify LVAD treatment for young heart failure patients

    Jupiter Endovascular secures funds to continue development of TFX platform

    SpectraWAVE appoints Jonathan Hill as chief medical officer

    SSi Innovations prepares FDA submission for Mantra surgical robot

    US FDA approves IDE for investigation of FLOWer embolic protection device

    Interim results of FIH study of CorWave LVAS shared at HFSA 2025

    Taho Pharma submits new drug application to US FDA for apixaban oral dissolving film

    Elixir Medical’s LithiX HC-IVL system gets full market release

    Omron blood pressure monitors exceed 400 million in sales

    DEEPER CORONARY study of Spur Elute retrievable scaffold system completes enrolment

    One in three deaths globally linked to cardiovascular disease

    Hearflow’s next-generation Plaque Analysis algorithm gains US FDA clearance

    BioCardia announces top line data from trial of CardiaAMP cell therapy procedure

    UK survey highlights wealth disparities in heart valve care

    SCAI initiative seeks to establish faster diagnosis of cardiogenic shock

    New preclinical data show early patency of coronary tissue engineered vessel

    SYMPHONY-PE trial demonstrates positive efficacy, efficiency, and safety results

    J-Valve TAVI system granted approval for treatment of aortic regurgitation in China

    CORE-MD consortium announces recommendations on clinical assessment of high-risk medical devices

    Mount Sinai establishes research centre focusing on AI in the cath lab

    Multicentre study to assess outcomes of TAVI and SAVR in bicuspid valves

    Cardiac Dimensions appoints William T Abraham as chief medical officer

    First patient receives Sutra Hemi-valve mitral repair system

    Neurescue device receives CE mark for treating non-shockable cardiac arrest

    First implantations of RoseDoc tricuspid valve replacement system begin in India

    Laza Medical announces milestone in use of its AI-based heart model for ultrasound-guided procedures

    Tria

    Tria mitral valve launches in India

    Timing DAPT based on risk score may reduce risk of adverse events

    ESC 2025: AQUATIC trial cautions against use of aspirin in chronic coronary syndrome patients receiving anticoagulation

    Imperative Care receives FDA 150k clearance for Symphony thrombectomy system

    shruthi narayan

    Shruthi Narayan appointed president of Penumbra

    Symplicity Spyral renal denervation system gains Japanese PDMA approval

    FDA begins ‘real-time’ reporting of adverse event data

    ESC 2025 hears long-term data from DANGER-SHOCK trial

    ESC 2025: Studies shed new light on antiplatelet therapy after CABG surgery

    ESC 2025: Baxdrostat shows promise in lowering blood pressure in uncontrolled and resistant hypertension

    ESC 2025: DUAL-ACS trial finds “less is more” for DAPT after acute MI

    SWEDEPAD re-opens paclitaxel safety discussion, finds drug-coated devices do not improve outcomes

    ESC 2025: REBOOT prompts rethink on use of beta blockers in uncomplicated MI

    ESC 2025: Trial results add digitoxin as an option for patients with advanced heart failure

    Roxana Mehran receives ESC Gold Medal

    ESC 2025: Guideline revisions include new TAVI age threshold

    Navitor TAVI valve picks up expanded CE mark for low-risk patients

    ESC 2025: “Minimalist” approach to TAVI may be an option for most patients

    Evolut TAVI systems gain US FDA approval for redo-TAVI procedures

    Favourable blood pressure and haemodynamic effects seen with AVIM therapy

    Paradise ultrasound renal denervation system gets approved for use in Japan

    Agent DCB to be studied in de novo coronary trial including bifurcations and long lesions

    US blood pressure guidelines bump up recommendation for renal denervation

    Spironolactone fails to lower cardiovascular risk in dialysis patients

    Image-guided crossing and re-entry system used for first time in coronary CTO trial

    Heartflow raises more than US$364 million through initial public offering

    Reprieve Cardiovascular announces funding and trial enrolment milestones

    APC Cardiovascular acquires Precision Surgical

    Gentuity and GE HealthCare collaborate to improve availability of imaging systems

    Wearable patch may speed up diagnosis of atrial fibrillation after cardiac surgery

    Total artificial heart system gains entry to US FDA advisory programme

    Competition concerns put Edwards’ JenaValve acquisition in jeopardy

    Japanese registry data support TEER in atrial functional mitral regurgitation patients

    ShortCut leaflet splitting device granted add-on payment designation by CMS

    First patients enrolled in MAGICAL-SV study of sirolimus DCB in small coronary vessels

    Orchestra BioMed secures additional capital from funding partners

    Sutureless aortic valve used for first time in RAVR procedure

    SRS 2025: Intercontinental robotic cardiac surgery completed using SSi Mantra 3 system

    Trial shows potential of low-level microcurrent stimulation in heart failure

    Surgeons perform pioneering robotic-assisted BiVAD implantation

    Medical devices MHRA

    MHRA announces UK medical device regulation amends

    First patient enrolled in continued access protocol trial of heart transplant technology

    AtriCure completes enrolment in trial assessing stroke prevention with AtriClip device

    Results of DECIDE registry presented at SCCT 2025

    Ceryx Medical closes latest funding round

    AI model able to predict onset of valve regurgitation

    Heart failure and AF increase risk of death or hospitalisation for patients undergoing transcatheter mitral repair

    Preliminary data “encouraging” for biorestorative coronary bypass conduit

    heart attacks

    Graft occlusion after CABG seen more often in female patients

    TAVI shown to have a lower carbon footprint than SAVR

    US FDA gives approval to commercialise AI software to guide transcatheter procedures

    Trial comparing TAVI and SAVR in aortic regurgitation enrols first patients

    CMS recommends coverage for renal denervation for hypertension

    CE mark approval for Biosensors’ Imperia THV delivery system

    Finerenone approved to treat heart failure patients

    US patent issued for algorithm to predict renal denervation response

    UK NICE recommends pulsed field ablation as AF treatment option

    Germany sees “exponential” growth in tricuspid interventions

    First patient receives CorWave left ventricular assist system

    CorFlow Therapeutics gains US FDA approval for IDE trial

    Merit Medical names Martha Aronson as new president and CEO

    First patient treated in trial of multi-organ denervation for uncontrolled hypertension

    VitalFlow ECMO system gains CE mark approval

    EARLY TAVR: Analysis looks at trial’s outcomes based on guideline recommendations

    First procedures performed in FRACTURE trial of Bolt IVL system in coronary artery disease

    CroíValve secures funding from Horizon Europe EIC Accelerator

    New York Valves hears 30-day results of low-profile TAVI valve

    Global study shows widening disparity in mitral valve disease outcomes

    Teleflex completes acquisition of Biotronik’s Vascular Intervention business

    First patient enrolled in EASE HF2 study of Intershunt technology for HFrEF treatment

    One-year results show positive safety and haemodynamic performance for biopolymer surgical mitral valve

    Improved survival seen following TAVI explant compared to redo procedures

    SEISMIC-HF I study assesses use of non-invasive HFrEF management technology

    Vivasure Medical submits premarket approval for PerQseal Elite vascular closure device

    Evoque tricuspid valve replacement system gains Health Canada approval

    First patient enrolled in RECOVER-AV trial of AlphaVac F18 system for treatment of acute PE

    Enrolment milestone met in CORCINCH-HF pivotal trial

    ADA 2025: Semaglutide taken orally shown to reduce cardiovascular risk in type 2 diabetes patients

    Study intensifies call for randomised trial in patients with bicuspid aortic stenosis

    Stroke rates diverge among TAVI and surgery patients at five years in pragmatic trial

    Ceryx Medical to develop physiologically responsive pacemaker following funding boost

    New medical device reporting requirements come into effect in the UK

    Prevencio granted patents to protect proprietary coronary artery disease blood test platform

    Enrolment completed in ATHENS-HF first-in-human study of Adona interatrial atrial shunt

    MedHub-AI and Terumo partner to distribute AI-powered FFR system in Japan

    Funding round allows completion of RESPONDER-HF trial of Corvia atrial shunt

    EMPACT-MI analysis “reassuring” on use of empagliflozin in patients with poor kidney function

    Aventus thrombectomy system gains FDA clearance for PE treatment

    Penumbra’s STORM-PE randomised trial completes enrolment

    TRANSFORM II study of sirolimus DCB completes patient enrolment

    Atraverse closes US$29 million to boost commercialisation of Hotwire transseptal access technology

    EuroPCR 2025: Thirty-day results show promise for Lux-Valve Plus TTVR system

    Surgical ablation during CABG carries survival advantage for patients with preexisting AF

    Tria polymer mitral valve gains Indian CDSCO approval

    Trial of DCB and scaffold technologies enrols first CTO-PCI patients

    FastWave Medical announces successful 30-day first-in-human data on Sola IVL technology

    Boston Scientific withdraws TAVI devices from the market

    EuroPCR 2025: Myval shows promise in latest comparative studies against contemporary TAVI platforms

    Abbott’s Tendyne TMVR system gains US FDA approval

    Prevail DCB gains expanded CE mark indications

    EuroPCR 2025 hears early outcomes of Topaz TTVR system

    EuroPCR 2025: DynamX coronary bioadaptor “durable” through three years

    EuroPCR 2025: Three-year data available for Freesolve resorbable magnesium scaffold

    Medtronic TAVI platforms gain CE mark for expanded redo TAVI indication

    EuroPCR 2025: Sustained reduction in TR seen at two years with Triclip in real-world data

    EuroPCR 2025: Search for suitable candidates for cerebral embolic protection continues

    Trial seeks to demonstrate benefit of ultra-low dose X-ray technology

    EuroPCR 2025: All-female coronary IVL trial reports positive outcomes at 30 days

    Cordis initiates SELUTION global coronary registry of coronary DCB

    Philips introduces VeriSight Pro 3D ICE catheter in Europe

    Cytokinetics shares topline results from MAPLE-HCM trial

    FAVOR III identifies major risk factors of cardiovascular events after PCI

    “Urgent need” to move away from lead in mitigating cath lab radiation exposure

    TRIOMPHE

    Endospan announces positive 30-day outcomes from TRIOMPHE IDE study

    Early analysis of BIOPATTERN trial offers insights on make-up of coronary plaque

    Heartflow shares two-year data from FISH&CHIPS study

    Inquis Medical’s Aventus thrombectomy system found safe and effective for patients with PE

    FastWave Medical to commence coronary feasibility study of laser IVL system

    SCAI names Srihari S Naidu as president

    SCAI 2025: Early TAVI “should be preferred to clinical surveillance in all age groups”

    SCAI 2025: Novel leaflet modification technique shows promise in reducing LVOT obstruction in mitral valve replacement

    SCAI 2025: Stenting “improves long-term survival” for patients undergoing CTO PCI

    SCAI 2025: SAPT after TAVI should be considered “standard of care”

    CX 2025: Managing blood pressure with medical therapy may play a role in limiting AAA growth

    CX 2025: Bioresorbable scaffold technology has ‘potential to be a new paradigm for femoropopliteal endovascular intervention’

    Edwards’ Sapien 3 lands US FDA approval for the treatment of asymptomatic severe AS

    Virtue trial to compare sirolimus and paclitaxel DCB technologies

    STS launches risk calculator for ascending aorta and aortic root surgery

    SoloPace announces US FDA clearance and first-in-human use of TAVI temporary pacing system

    Transverse Medical completes first patient series involving Point-Guard CEP device

    PerQseal Elite vascular closure system gains CE mark

    Atrioventricular interval modulation therapy granted US FDA breakthrough designation

    Eight-year data “encouraging” for aortic valves using Resilia tissue technology

    Terumo brings Medis QFR 3.0 to US market

    Edward Lifesciences’ Sapien M3 transfemoral mitral valve system gains CE mark

    FFR-guided PCI catches up to CABG at five years in FAME 3 study

    First cases performed with AtriClip PRO-Mini LAA exclusion system

    Elixir Medical launches LithiX Hertz Contact IVL system in Europe

    Trial results open door to frozen plasma alternative for bleeding management in cardiac surgery

    STRIKE-PE interim analysis shows benefit for acute PE patients with syncope

    “Sustained” clinical benefits seen at six months in Altavalve early feasibility study

    HighLife granted US FDA breakthrough designation for TMVR system

    US FDA clears phase 3 clinical study of ASI-02 in patients undergoing TTE

    Shockwave commences trial of Javelin IVL catheter in complex coronary disease

    Post-TAVI pacemaker implantation linked to long-term increase in mortality rates

    DurAVR transcatheter heart valve reaches 100 patients

    ACC.25: Low-dose colchicine seen to reduce coronary plaque progression in EKSTROM trial

    CONFORM IDE trial reaches enrolment milestone

    Lancet Commission urges reframing of coronary disease towards atherosclerosis

    Teleflex announces US FDA clearance for AC3 Range intra-aortic balloon pump

    ACC.25: ECLIPSE study results support routine use of intravascular imaging during PCI of calcified lesions, investigators say

    ACC.25: TEER with Triclip reduces heart failure hospitalisation versus medical therapy among TR patients in TRILUMINATE trial

    ACC.25: Studies evaluate aortic stenosis referral and detection

    Early feasibility study of Siegel 8Fr TAVI valve launches

    ACC.25: ALIGN-AR reports positive outcomes with dedicated TAVI device for aortic regurgitation

    ACC.25: Evolut Low Risk trial shows comparable rates of all-cause mortality and stroke with TAVI and surgery at five years

    ACC.25: Cerebral embolic protection found not to reduce stroke in BHF PROTECT TAVI trial

    ACC.25: Semaglutide improves walk distance for PAD patients with diabetes

    ACC.25: Bentracimab can reverse bleeding complications linked to ticagrelor

    ACC.25: Rivaroxaban “a viable alternative to warfarin” in STEMI patients with left-ventricular thrombus

    Preliminary IDE trial results demonstrate efficacy of dedicated device for coronary perforations

    CRT 2025: New TAV-in-SAV data underline importance of aortic valve sizing at index procedure

    New funding to support expansion of clinical programme for Supira Medical pVAD

    PMcardio STEMI AI ECG tool earns US FDA breakthrough device designation

    Evident Vascular

    Evident Vascular raises Series B financing to advance AI-powered IVUS platform technology

    Abbott to begin TECTONIC trial of IVL therapy prior to coronary stenting

    Cardiac Dimensions secures financing to complete EMPOWER trial

    CRT 2025: First-in-human cases using robotic-assisted TMVR system performed in Chile

    GE HealthCare launches AltiX AI.i editions of its Mac-Lab, CardioLab and ComboLab systems

    SMARTFLOW study to assess diagnostic accuracy of AI-powered angiography image interpretation software

    Protembis names four-person advisory board

    CRT 2025: AGENT IDE trial results “consistent” out to two years using DCB in ISR

    Research project seeks to update cardiovascular risk calculations using latest technology

    Laplace Interventional closes series C financing round

    Valcare Medical receives US FDA approval to initiate EFS for Amend transseptal system

    CRT 2025: Acurate neo2 shows “reassuring” performance in observational study after stuttering IDE trial

    Global Cardiovascular Awards – The full list of winners and highly commended entries

    Innovation and excellence celebrated at second Global Cardiovascular Awards

    Howard Herrmann appointed CMO for structural heart by Affluent Medical

    CRT 2025: ATTENUATE trial shows significant radiation reduction in cath lab procedures using protective drape

    CRT 2025: Improved haemodynamics seen with supra-annular TAVI system at two years in SMART trial

    CRT 2025: SCAAR analysis shows comparable outcomes between Prevail and other DCBs

    Josep Rodés-Cabau named as editor-in-chief of Structural Heart

    Reflow Medical expands global reach with new European subsidiary

    Boston Scientific among investors in latest financing round for 4C Medical Technologies

    SCAI highlights cath lab radiation and orthopaedic hazards

    heart attack

    New partnership aims to develop platform for treating heart failure

    Shockwave Medical announces US launch of intravascular lithotripsy catheter

    Cadrenal Therapeutics and Abbott to collaborate on TECH-LVAD trial

    Stereotaxis seeks to broaden use of its robotic magnetic navigation system into multiple endovascular fields

    DeepQure advances clinical trials of its HyperQure extravascular renal denervation system

    Boston Scientific to acquire renal denervation technology developer SoniVie

    First US commercial cases performed with ShortCut leaflet modification device

    Pulnovo Medical closes series C financing round in support of two US FDA trials

    MyOme launches coronary artery disease polygenic risk assessment tool

    ACC and AHA acute coronary syndrome guidelines stress radial approach

    Teleflex announce acquisition of Biotronik’s Vascular Intervention business

    Biotronik partners with Egg Medical to bring radiation protection systems to US healthcare workers

    Medtronic commences Prevail Global study as it seeks coronary DCB approvals in USA and Japan

    First US centres use GE HealthCare’s Flyrcado cardiac PET imaging agent

    SCAI offers guidance on alternate access for TAVI

    Drug therapy may slow progression of aortic valve stenosis

    RANGO registry reports long-term safety and efficacy of Angiolite DES

    Biotronik’s Freesolve resorbable scaffold to be studied in long lesions

    Sotagliflozin “shows new mechanism of action” in reducing heart attack and stroke among diabetics, kidney disease patients

    Economic analysis supports cost-effectiveness of Guardian monitoring system in high-risk acute coronary syndromes

    THT 2025: eLym system “promising” for treatment of fluid overload in ADHF patients

    THT 2025: MODERATO II study demonstrates improved echo markers of diastolic dysfunction through AVIM therapy

    American Society of Echocardiography releases new guideline on ultrasound-guided vascular access

    THT 2025: Reprieve system meets endpoints in FASTR randomised pilot study

    Coronary CT angiography-guided management of stable chest pains shows benefit out to 10 years

    Studies add fuel to debate over choice of surgical or transcatheter strategies in dual treatment of aortic and coronary disease

    Data and device tweaks herald ‘practice-changing’ future for bioabsorbable scaffolds

    First experience of novel transseptal puncture device shared at STS 2025

    Study weighs up discordance between bleeding risk calculation tools

    Lifemotion ECMO system receives CE mark certification

    AVS completes US$36 million Series B financing ahead of IVL US commercial launch

    Full IDE dataset from AMDS PRESERVE trial presented at STS 2025

    EACTS launches grant scheme for heart valve care in underserved regions

    STS 2025: Analysis sheds light on impact of surgeon preference in choice of multi- versus single-arterial grafting in CABG

    Joseph Sabik elected STS president

    STS 2025: Mechanical aortic valves “confer a significant survival advantage” in patients under 60

    Atraverse announces clinical evidence validating Hotwire radiofrequency guidewire system

    NFL stars to get HeartFlow analysis through GAMEFILM registry study

    First commercial cases using CrossFAST advanced delivery system performed in USA

    Accuryn monitoring system detects kidney injury in cardiac surgery patients “earlier than standard serum creatine criteria”

    Caranx Medical makes US FDA submission for AI TAVI guidance software

    Factor XI inhibitor ‘lives up to promise’ of reduced bleeding events in AF patients

    FastWave

    FastWave issued seventh utility patent for its IVL portfolio

    Humacyte files for investigational use of tissue engineered vessel in CABG

    US FDA announces plans to address medical device shortage risks

    Pivotal trial of dissolving film oral anticoagulant reaches completion

    Advanced Bifurcation Systems secures latest round of funding

    Surgeons claim “world first” robotic artificial heart pump implant

    Circa announces successful first procedures with Crosswise RF transseptal access system

    Cardiac surgery societies endorse ESC coronary revascularisation recommendations

    Alleviant Medical secures funding for second pivotal trial of no-implant atrial shunt

    CMS launches review of coverage for renal denervation

    Biotronik nets short DAPT and calcified lesion indications for Orsiro Mission DES

    CoreMedic and InnoRa partner to accelerate development of ChordArt mitral repair system

    APEX-AV trial results of AlphaVac PE system published in JSCAI

    AVENTUS trial of thrombectomy system for PE treatment completes enrolment

    Piccolo Medical announces distribution agreement with Spectrum Vascular

    Argon Medical enrols first patient in CLEAN-PE study

    First patients treated in TRICURE EFS study of Topaz tricuspid heart valve replacement system

    Relief Cardiovascular closes financing round to fund first-in-human study

    Boston Scientific to acquire IVL developer Bolt Medical

    Study finds adverse outcomes after decreased use of paclitaxel-coated devices

    Simpson Interventions announces US FDA regulatory milestones

    Alleviant Medical to commence pivotal trial of no-implant atrial shunt in HFrEF patients

    US FDA issues first draft guidance for AI-based medical device development

    Harmony transcatheter pulmonary valve gains CE mark

    RevoEdge high-pressure coronary cutting balloon gains CE mark

    Enrolment completed in ALL-RISE trial of FFRangio coronary physiology assessment

    First-in-human results “demonstrate potential of Reprieve system” in ADHF treatment

    First phase of BiVACOR early feasibility study completed

    First patients enrolled in JENA-VAD registry

    FastWave Medical closes $19 million financing round to advance IVL portfolio

    impella in preventing heart failure in stemi patients

    Impella heart pump approved for use in paediatric patients

    Vantis Vascular completes series B financing round

    Developer of robotic heart valve system closes financing round

    Initial shortlist for Global Cardiovascular Awards revealed

    First-in-human study of Protaryx transseptal puncture technology completed

    Terumo and Medis partner on coronary imaging technology

    Pilot study shows cryoablation safe and effective for patent foramen ovale closure in AF patients

    PCR London Valves 2024: Live cases at cardiology conferences “do not compromise patient safety”

    PERIGON trial demonstrates durability of Avalus aortic valve at seven years

    TCT 2024 hears early experience with high-definition IVUS system

    PCR London Valves 2024: New data presented alongside launch of latest-generation Myval device

    FastWave issued sixth utility patent for its IVL portfolio

    WVU team performs pioneering combined robotic aortic valve replacement and coronary bypass procedure

    PCR London Valves 2024: Medtronic shares Evolut cusp overlap and PVL data

    Heart Valve Voice marks 10-year milestone

    Scottish centres adopt on-screen system for endoscopic vessel harvesting

    Abbott launches its largest Navitor Vision valve size in UK

    Health Canada approves Wegovy for non-fatal MI reduction

    ACURATE IDE results put spotlight on impact of valve under-expansion after TAVI

    First patient procedures performed with Abbott’s balloon-expandable TAVI system

    PCR London Valves 2024: One-year data affirm clinical performance of Sapien 3 Ultra Resilia TAVI system

    CAPTURE-1 study of EmStop embolic protection system concludes

    First patients enrolled in high-risk PCI study of Supira pVAD

    AHA 2024: Five-year Amulet IDE data show similar outcomes with Amplatzer and Watchman devices

    First patient enrolled in trial of Cysoni temporary pacing technology

    heart attacks

    ALERT study to use AI to identify underserved patients eligible for TAVI

    Second Heart Assist announces further high-risk PCI cases using Whisper mechanical circulatory support device

    AHA 2024: OPTION trial reports positive outcomes for Watchman FLX at three years after AF ablation

    AHA 2024: Edoxaban an “effective alternative” to warfarin following valve replacement surgery

    AHA 2024: Spironolactone misses primary endpoints in CLEAR SYNERGY trial

    BrightHeart gains US FDA clearance for AI ultrasound software for detecting congenital heart defects

    Early valve replacement falls short in EVOLVED trial

    Orbital atherectomy fails to eclipse balloon angioplasty in randomised trial in severely calcified lesions

    Trilogy valve shows favourable results at two years in aortic regurgitation patients

    CONFIRM-2 registry demonstrates use of AI-enabled quantitative CT for predicting MACE

    Initial results of Sikelia transcatheter heart valve shared at TCT 2024

    CABG shows benefit over PCI in patients with diabetes and multivessel disease in Swedish registry study

    Shockwave Javelin peripheral IVL catheter meets prespecified efficacy and safety performance goals in feasibility and IDE studies

    Two-year LIFE-BTK data show sustained benefits of drug-eluting resorbable scaffold for below-the-knee arteries

    US FDA approves IDE application for Katana thrombectomy system

    First patient enrolled in study of integrated laser atherectomy and IVL catheter

    TCT 2024: Drug-eluting resorbable scaffold proves cost effective at one year in LIFE-BTK analysis

    CMS grants transitional pass-through payment for Medtronic’s Symplicity Spyral and Recor’s Paradise renal denervation systems

    TCT 2024 hears one-year results of TRAVEL II study of transcatheter tricuspid replacement system

    TCT 2024: Six-month data reflect safety and efficacy of Lithix HC-IVL system

    TCT 2024: TRISCEND II reports positive outcomes for tricuspid replacement system

    TCT 2024: New analysis shows difference in rates of stroke among US and non-US cohorts of PROTECTED TAVR trial

    TCT 2024: Two-year SPYRAL HTN-ON MED show “consistent” effect of renal denervation

    TCT 2024: PEERLESS trial finds large-bore mechanical thrombectomy superior for intermediate-risk PE

    TCT 2024: One-year data from SIRONA trial show similar results for sirolimus versus paclitaxel DCB

    TCT 2024: New evidence could prompt rethink over use of colchicine following acute MI

    TCT 2024: PATCH study reports initial positive results for sutureless vascular closure system

    TCT 2024: Non-invasive ultrasound therapy device shows promise in calcific aortic stenosis

    TCT 2024: Coronary bioadaptor shows clinical benefit in complex PCI sub-groups

    TCT 2024: EARLY TAVR shows early intervention may be fruitful in asymptomatic aortic stenosis

    EMPOWER CAD all-female IVL trial completes enrolment

    TCT 2024: TAVI does not shift the dial in heart failure patients with moderate aortic stenosis

    TCT 2024: Adjustable valve replacement system wins Shark Tank innovation prize

    Adona interatrial shunt used in first human cases

    TCT 2024: Seven-year registry data confirm use of AI-enabled FFRCT

    First US cases performed with Vertex PE system in SPIRARE II pivotal study

    First-in-human results for dual-drug therapy DCB released

    TCT 2024 live blog

    Medtronic receives US FDA approval of Affera mapping and ablation system and Sphere-9 catheter

    First patients treated with Duo tricuspid coaptation system in TANDEM II study

    NICE recommends use of HeartLogic heart failure diagnostic

    Medtronic’s Evolut FX+ TAVI system gains CE mark

    First-in-human implants with Luna TMVR system completed

    Medtronic’s Prevail DCB to be studied in US IDE trial

    Gentuity HF-OCT imaging system receives FDA clearance

    COVID-19 infection may increase risk of heart attack up to three years later

    Study highlights mortality disparity among minority patients undergoing CABG

    EACTS 2024: Robotic aortic valve replacement shows promise as an alternative to TAVI

    MedTech Innovation Forum returns at TCT 2024

    Kaminari Medical closes €3.8 million financing round to advance intravascular imaging system

    Ian Meredith joins board of directors at Transverse Medical

    EACTS 2024: Digital “prehabilitation” programme reduces adverse events after cardiac surgery

    J&J completes acquisition of V-Wave

    AI

    AI-based aortic stenosis screening software gains US FDA breakthrough designation

    Pivotal trial of AltaValve TMVR system commences in USA and Europe

    EMBLOK enrols 50th patient in TAVI embolic protection trial

    FASTR trial of Reprieve system completes enrolment

    ESC 2024: Chronic coronary syndrome guidelines clarify role of revascularisation and strengthen imaging recommendations

    Randomised trial results support pausing anticoagulation prior to TAVI

    AtriCure’s launches EnCompass clamp in Europe

    GLACE study to assess ICE imaging during LAA closure

    US FDA clears Elucid’s PlaqueIQ imaging analysis software

    HFSA 2024: Aficamten shows improvement in clinical markers used to inform HCM care

    HFSA 2024: One-year data from PROACTIVE-HF show reduction in heart failure hospitalisation and all-cause mortality

    Three-year data from ASSURED study of Cardioform ASD occluder released

    Renal denervation gains class IIb recommendation in ESC guidelines

    ShortCut leaflet splitting device gains US FDA market clearance

    US FDA approves Flyrcado injection PET radiotracer for diagnosis of coronary artery disease

    Medtronic launches VitalFlow ECMO system

    Meta-analysis supports DAPT de-escalation after PCI

    heart attacks

    UK societies call for concerted effort to tackle cardiovascular disease in women

    SSCORE registry of super saturated oxygen therapy in LAD STEMI patients begins

    Pooled analysis of over 18,000 participants supports benefits of finerenone across cardio-kidney-metabolic conditions

    Latest TRILUMINATE and TRI.Fr data add to growing body of evidence for tricuspid TEER

    Cerenovus and Biosense Webster among brands newly incorporated into Johnson & Johnson MedTech

    First Topaz tricuspid valve implanted in European pivotal study

    TEER non-inferior to surgery in MATTERHORN trial but dividing lines remain

    First cases completed in SPIRARE I trial with Vertex system

    AI

    AI powered structural heart planning software gains US FDA clearance

    PlaqueTec and RxCelerate collaborate on early phase drug discovery for coronary artery disease

    Novostia announces new funding and leadership changes

    Philips announces US FDA approval for enhanced LumiGuide guidewire, marks 1,000th patient treated with 3D device guidance technology

    No-touch graft harvesting technique shows “no benefit, but significant harm” in SWEDEGRAFT study

    SpectraWAVE eyes commercial expansion of its HypreVUE intravascular imaging system

    CorFlow completes series B funding round to evaluate therapeutic treatments for MVO using CoFl system

    Brightflow SAS raises €16.5M in series A financing round

    AI-powered point-of-care ultrasound system gains US FDA approval

    First two TAVI procedures completed using Venus-Vitae valve in SMART ALIGN trial

    ESC 2024: Coronary bioadaptor non-inferior to DES at one-year for TLF

    ESC 2024: New evidence suggests fasting not needed before cardiac catheterisation procedures

    ESC 2024: Invasive strategy does not reduce risk of cardiovascular death or non-fatal MI in older NSTEMI patients

    ESC 2024: TAVI “superior” to surgery in women with severe aortic stenosis

    ESC 2024: “No need” for potassium supplementation after CABG

    ESC 2024: RESHAPE-HF2 results move conversation forward on effectiveness of TEER in functional MR

    New ESC guidelines combine peripheral arterial and aortic diseases for first time, emphasising interconnectivity of whole arterial system

    ESC hypertension guidelines stipulate conditions for renal denervation use

    ESC 2024: Remote echocardiograms offer “relatively good diagnostic accuracy”

    ESC 2024

    ESC 2024 Congress live blog

    First patient treated with AtriClip FLEX-Mini LAA device

    Acurate Prime TAVI system gains CE mark

    ESC 2024: AI virtual voice assistant identifies complications after TAVI

    Brightflow appoints Sophie Humbert as CEO

    AtriClip LAA device receives expanded indication

    AI-based point-of-care ultrasound software gets US FDA clearance

    Nanox receives FDA approval for its latest generation AI platform for coronary disease detection

    Labelling change allows removal of aspirin following HeartMate 3 implant

    SCOREPAD seeks to address “alarmingly high” mortality in CLTI patients with underlying coronary disease

    Johnson & Johnson to acquire V-Wave

    AVS and Jacobs Institute partner on study of Pulse IVL system

    Jupiter Endovascular secures multimillion dollar financing round

    Genesis MedTech announces sale of JC Medical to Edwards Lifesciences

    Medical advisory board appointed to lead innovation at Radiaction

    Survey highlights complication rates among pregnant cardiology trainees

    AI models have potential in heart team decision-making, but beware blindspots

    BioCardia submits 510(k) approval for Morph DNA steerable introducer sheath family

    NMPA approves SyMap renal denervation system for treatment of uncontrolled hypertension

    Funding allows CroíValve to advance US early feasibility study of Duo tricuspid valve

    heart attack

    Trialists call for rethink over use of MACE as a primary endpoint in cardiovascular trials

    Ringer perfusion balloon catheter gains US FDA approval

    EU bank finances maker of ProtEmbo cerebral embolic protection system

    SavvyWire pre-shaped pressure guidewire gains CE mark

    Bavaria joins board of directors at PECA Labs

    Diabetic PCI patients have a higher risk of stent failure without glycaemic control

    Texas Heart Institute performs first-in-human implantation of BiVACOR total artificial heart

    AMEND TS EU pilot study of mitral valve repair device expands to Italy

    First patients treated in US GPS study of Paradise renal denervation system

    SoniVie announces advancements in its renal denervation programme

    Abbott’s Navitor Vision TAVI valve rolled out in UK and Ireland

    Edwards Lifesciences continues acquisition spree, announcing JenaValve and Endotronix deals

    Prevencio receives US patent for AI-powered test of obstructive coronary artery disease

    Latest round of funding secured to boost clinical programmes for Topaz tricuspid valve system

    Funding secured to support clinical study of Elevate heart pump

    AtriClip LAA exclusion system granted approval for marketing in China

    RSA-pace study of Cysoni-XT temporary pacing system granted approval

    Royal Brompton Hospital installs UK’s first Magnetom Cima.X MRI system

    ContraBand pulmonary artery banding system gains US FDA breakthrough status for HFrEF treatment

    Elucid begins site recruitment for PRE-VUE CT study

    Materialise announces FEops acquisition to offer “interactive” planning for structural heart procedures

    New publication highlights performance of iVascular’s Essential pro DCB

    Consumer wearables found to have clinical value in assessing treatment for AF and heart failure

    First US heart failure patient receives V-LAP left atrial pressure sensor

    Edwards Lifesciences to acquire TMVR developer Innovalve

    Health Canada grants approval for use of Pascal Precision to reduce significant, symptomatic MR

    Global Cardiovascular Awards return in 2025

    TruLeaf Medical to commence clinical trial of RoseDoc two-stage TMVR system

    heart attacks

    New research highlights sex disparity in treatment of CABG patients

    MANIFEST-17k registry shows promising safety performance for PFA

    Adona Medical secures financing to initiate clinical use of interatrial shunt device

    US FDA approves Cordis’ Mynx Control venous vascular closure device

    Financing secured to develop “personalised” tricuspid repair system

    Orsiro Mission DES available in expanded maximum allowed diameters range

    Anteris Technologies and v2vmedtech reach concept lock on VClip TEER system

    DEEPER CORONARY trial of Spur system for coronary in-stent restenosis gets underway

    First patients enrolled in study of pulmonary artery denervation treatment

    Valcare Medical appoints scientific advisory board to guide development of mitral annuloplasty device

    CardioFlow’s second-generation TAVI system gains CE-MDR certification

    FASTIII trial of angiography-based vessel fractional flow reserve completes enrolment

    DynamX sirolimus-eluting bioadaptor system gains US FDA breakthrough designation

    Cordis announce positive 24-month results from Selution SFA Japan trial

    Cardiac-MRI data from DurAVR FIH study shared at New York Valves

    Six-month TANDEM I results “promising” for Duo tricuspid coaptation system

    DeepQure receives IDE approval of extravascular renal denervation system to treat resistant hypertension

    Biopolymer surgical mitral valve sees favourable results at 30 days

    Abbott receives CE mark for Aveir dual chamber leadless pacemaker system

    First-in-human results with Mirus Siegel TAVI valve presented at New York Valves 2024

    Investigators find small reduction in disabling stroke from embolic protection device use

    New York Valves hears five-year data from PARTNER trials focused on small annulus patients

    Edwards Lifesciences to strengthen structural heart business after sale of Critical Care group

    HighLife to initiate US pivotal study of transseptal mitral valve replacement system

    First patients treated in pilot study of Half Moon TMVR device

    Shockwave Medical

    Johnson & Johnson completes acquisition of Shockwave Medical

    First transseptal TMVR with Saturn valve performed in CASSINI-EU study

    Terumo Cardiovascular gains US FDA clearance for CDI OneView monitoring system

    FastWave Medical announces successful 30-day first-in-human data on peripheral IVL technology

    Valentin Fuster given WHF Lifetime Achievement Award

    US FDA gives breakthrough device designation for lipoprotein blood test

    BIOMAG-I two year results confirm safety and efficacy of Biotronik resorbable magnesium scaffold

    EuroPCR 2024: Coronary implant with “site-specific” antithrombotic delivery shows promise at one year

    First patients enrolled in AMEND TS pilot study

    EuroPCR 2024: Leaflet splitting device may offer efficient option for avoiding coronary obstruction during valve-in-valve procedures

    GE Healthcare and Medis Medical collaborate to commercialise QFR technology

    EuroPCR 2024: Coronary bioadaptor system shows sustained reduction of TLF at two years in BIOADAPTOR RCT

    Anteris Technologies reports successful deployment of DurAVR in challenging valve-in-valve case

    EuroPCR 2024: SMART trial data offer new insight on TAVI device choice in women

    EuroPCR 2024: TAVI device with intermediate sizing shown to be non-inferior to contemporary platforms in LANDMARK trial

    EuroPCR 2024: NOTION-2 one-year results prompt questions over TAVI in young, low-risk patients with bicuspid aortic valves

    CathWorks’ FFRangio system gains approval under EU MDR

    First patient enrolled in BIOMAG-II trial of Freesolve resorbable scaffold

    Global Heart Hub shares findings from the Patients living with Elevated Cholesterol data programme

    IVUS-guided PCI comes out on top over angiography in trial in acute coronary syndrome patients

    Women and black patients less likely to receive catheter-based treatment for pulmonary embolism

    Edwards’ Sapien 3 Ultra Resilia valve gets European launch

    AltaValve granted US FDA breakthrough device designation

    Two-year echocardiographic data from REDUCE LAP-HF II trial published in JAMA Cardiology

    Patient wellbeing and satisfaction improve without drop in safety after non-fasting strategy prior to cardiac catheterisation

    US analysis demonstrates superiority of radial access for PCI

    SCAI 2024 hears additional analysis from SMART trial

    Medtronic’s Symplicity Spyral system approved for use in China

    EACTS launches Innovation Hub to boost investment in surgical innovation

    PCI for stable coronary artery disease can be performed safely before, during or after TAVI

    Atrial fixation TMVR device may have reduced risk of LVOT obstruction

    Performance of single-piece biomimetic transcatheter heart valve “encouraging”, first-in-man results indicate

    Wattson temporary pacing guidewire begins limited market release

    Abbott’s Esprit BTK scaffold system given US FDA approval for CLTI treatment

    STS updates risk calculators for tricuspid surgery, CABG and SAVR after TAVI

    Medtronic announces US launch of Avalus Ultra surgical aortic valve

    AATS joins as surgical partner of New York Valves meeting

    Biotronik to distribute Texray radiation protection products

    MAGICAL-ISR study of MagicTouch sirolimus DCB commences

    CX 2024: Paclitaxel device restrictions “did cause harm”

    Tria

    Tria valves surpass 200 patient life years

    Fastwave Medical issued fourth utility patent for laser-IVL platform

    Acolyte system for guidewire positioning and placement in CTOs given US FDA breakthrough device status

    Caranx Medical announces successful robotic TAVI procedure in an animal

    Olivier Pierron joins Cardiawave SA as chief executive officer

    First large bore venous patient treated with PerQseal Elite vascular closure system

    Transverse Medical restructures board as it seeks to bring cerebral embolic protection system to market

    heart attack

    Clinical study of CADScor system to identify non-obstructive coronary artery disease in chest pain patients gets underway

    ACC 2024: Use of Impella CP may boost survival in STEMI patients with cardiogenic shock

    ACC 2024: ORBITA-COSMIC shows reduction in chest pain in angina patients receiving coronary sinus reducer, but questions still remain

    heart attacks

    Survey highlights lack of awareness of among women of heart valve disease and risk factors

    ACC 2024: Self-expanding valve comes out on top at one year in SMART trial comparing TAVI devices in small aortic annuli

    ACC 2024: Interatrial shunt fails to meet primary endpoint in RELIEVE-HF trial

    Johnson & Johnson to acquire Shockwave Medical

    ACC 2024: AEDs used in a small number of cardiac arrest cases, despite proximity

    One in 10 deaths after PCI found to be “preventable”, US state-wide analysis suggests

    AI software integrated into GE Healthcare’s Vscan Air SL handheld ultrasound imaging system

    Leadership change at TRiCares sees Atricure and Medtronic veteran join as president and CEO

    TriClip TEER system for TR repair given US FDA approval

    PROTEMBO randomised trial of three-vessel cerebral embolic protection device enrols first patient

    Winrevair given US FDA approval for the treatment of pulmonary arterial hypertension

    Cardiac surgeon and interventional cardiologist join egnite’s medical advisory board

    Latest-generation Evolut TAVI system gains US FDA approval

    US registry launches to evaluate physician decision-making using HeartFlow Plaque Analysis

    ENVISION trial of Abbott’s Navitor TAVI valve in low-risk patients enrols first patient

    CRT 2024: Shield system cuts operator exposure to radiation during cath lab procedures

    CRT 2024: US DCB approval provides “important treatment option” for in-stent restenosis

    Robotic system “brings transcervical aortic valve replacement a step closer”

    BioCardia announces long-term partnership with StemCardia

    Health Canada licenses Symplicity Spyral radiofrequency renal denervation system to treat hypertension

    Funding round closes in support of ConKay annuloplasty system for TR treatment

    Global Cardiovascular Awards – The full list of winners and highly commended entries

    Past, present and future of cardiovascular innovation celebrated at Global Cardiovascular Awards

    Cost-effectiveness and updated efficacy data from Evolut Low Risk trial shared at CRT 2024

    Gilbert Tang named as editor-in-chief of JACC: Case Reports

    HeartFlow shares ten-year data from DISCOVER-FLOW study

    First mitral valve replacement performed using SSi Mantra robotic system

    CRT 2024: SAFE-MCS finds reduction in bleeding for high-risk PCI patients with bleed monitoring system

    Sapien 3

    CRT 2024: New data on outcomes with Sapien TAVI platform

    US FDA approves weight loss drug Wegovy to prevent cardiovascular events

    PulseCath’s iVAC 2L gains MDR certification

    Cleerly receives US FDA breakthrough designation for CAD staging system

    PROACTIVE-HF pivotal trial of Cordella pulmonary artery sensor meets primary endpoints

    Trial of autologous cell therapy in advanced chronic heart failure reports interim results at THT 2024

    FastWave Medical gains third patent from USPTO for IVL system

    Mobile clinical research specialist Hawthorne Effect appoints new CEO

    Boston Scientific’s Agent DCB gains first US FDA coronary approval

    EACTS and STS guidelines recognise aorta “as an organ in its own right”

    Philips launches new motorised mobile C-arm system

    Patient enrolment completed in study of remote heart failure monitoring device

    heart attack

    First patient treated using A-Flux Reducer interventional system for angina

    Tria

    Foldax agrees manufacturing agreement with Dolphin Life Science India

    First cases using Laminar LAAX system performed as part of IDE study

    Ismail El-Hamamsy named as president of Heart Valve Society

    First procedure completed using Laplace tricuspid valve replacement system

    Philips announces LumiGuide 3D imaging technology availability in Europe and USA

    Todd Berg joins NeoChord as CEO

    Analyses provide “hard evidence” of benefit of intravascular imaging-guided PCI

    Australian government offers grant support to artificial heart programme

    Reprieve Cardiovascular secures multimillion dollar financing

    Global registry charts pandemic’s impact on TAVI volumes

    Alain Cribier: 1945–2024

    TriClip gets positive vote from US FDA advisory panel

    Biotronik’s Freesolve resorbable magnesium scaffold gains CE mark

    BHF PROTECT-TAVI trial poised to answer key questions about use of cerebral embolic protection during TAVI

    FLOWer embolic protection device gains CE mark

    Biotronik launches Micro RX microcatheter to the US market

    SonieVie

    Study of TIVUS renal denervation system for hypertension treatment completes enrolment

    VenusP-Valve

    Health Canada approves VenusP-Valve transcatheter pulmonic valve replacement system

    Early feasibility study of TAVI platform for treatment of aortic regurgitation completes enrolment

    STS 2024: Large registry study demonstrates superiority of multi-arterial grafting for multivessel revascularisation

    Evoque becomes first transcatheter tricuspid system to gain US FDA approval

    AI

    AF Symposium 2024: AI-enabled predictive pre-planning “significantly improves LAAO procedural efficiency”

    Cast your vote for the Heart Team of the Year

    SCAI publishes expert consensus statement on calcified coronary lesions

    Philips’ “mini” 3D TEE transducer granted US FDA approval

    TRIOMPHE

    Endospan releases early TRIOMPHE IDE study results at STS 2024

    STS 2024: STS elects its first female president

    STS 2024: Data show shift in the proportion of patients under 60 receiving TAVI instead of SAVR

    French registry study finds fewer cardiovascular deaths among mitral regurgitation patients receiving TEER

    Early feasibility study of CroíValve’s Duo tricuspid coaptation valve system launches

    Simona Zannetti returns to Medtronic to lead aortic business

    Collaboration aims to develop a bespoke cell phenotyping assay for human blood

    Three valve-in-valve procedures completed using DurAVR transcatheter valve

    US FDA grants breakthrough designation for Pi-Cardia’s ShortCut leaflet splitting device

    See the full shortlist for the Global Cardiovascular Awards

    First-in-human implant of Triflo heart valve completed

    Radiofrequency renal denervation meets cost efficiency threshold in value analysis

    FastWave Medical announces completion of first procedures in study of novel peripheral IVL system

    Study shows no safety risk in allowing patients to eat prior to cardiac catherisation

    “Structural heart leader” joins Cardiac Dimensions as chief medical officer

    Penumbra launches Indigo system CAT RX catheter in Europe to treat acute coronary syndrome

    Occlutech to launch atrial septal defect occluder in the USA

    US FDA grants clearance for VR surgical planning software from Realize Medical

    First patient randomised in BACKBEAT study of AVIM therapy for uncontrolled hypertension

    US FDA approves ENGULF US pivotal trial of Hēlo thrombectomy system

    Medical cannabis for chronic pain may increase risk of arrhythmia

    Cook Medical announces Slip-Cath Beacon Tip catheter is now available in the USA and Canada

    SCAI, SIR, SVS jointly publish proceedings from multispecialty peripheral IVUS roundtable

    GE HealthCare to acquire AI-imaging specialist

    R-One robotic platform given green light to enter Chinese market

    Endotronix submits premarket approval application to US FDA for Cordella pulmonary artery sensor

    Edwards Lifesciences appoints its first US case observation site under Benchmark TAVI programme

    Topaz tricuspid valve replacement system used for the first time in a patient with a pacemaker

    Chilean centre treats five aortic regurgitation patients in a single day with Zeta TAVI system

    HeartFlow’s FFRCT analysis passes 250,000 patient milestone

    Pulse Biosciences files premarket US FDA 510(k) notification for its CellFX nsPFA cardiac clamp

    Investors offer backing for developer of transcatheter mitral chord repair technology

    First patient treated in ARISE II study of Gore ascending stent graft

    Blood potassium monitor under development to benefit patients with chronic renal failure

    LUMA Vision secures US$22 million in financing

    CE mark trial of Optimum TAVI valve given green light for expansion

    Microbot Medical and Corewell Health announce telerobotics collaboration

    Early use of mechanical support shows benefit for patients with AMI complicated by cardiogenic shock

    ANGIODAPT trial launches with first patient enrolment

    First-in-man cross-country robotic coronary angioplasty performed in two Chinese centres

    First patient treated with PerQseal Elite vascular closure system

    Haemonetics completes acquisition of OpSens

    Consortium to assess use of CT to improve diagnosis and treatment of coronary artery disease

    Mortality from cardiovascular disease continues to increase globally

    Pi-Cardia appoints Gary Gratson to lead commercialisation of ShortCut

    Warfarin lowers mortality risk after SAVR

    Harlan M Krumholz named as JACC editor-in-chief

    Projected rise in aortic valve-in-valve procedures prompts interest in leaflet splitting device

    Catheter Precision’s VIVO 3D mapping system secures reimbursement in NHS England’s SSDP

    Kaneka Corporation acquires Japan Medical Device Technology Co

    Carmat increases capacity with opening of second production facility

    Medtronic launches Penditure left atrial appendage exclusion system in the USA

    First patients join pivotal trial of Aortix pump for treatment of acute decompensated heart failure

    Johnson & Johnson acquires Laminar

    Next-generation Palmetto TMVR system gets first-in-man use

    Bivacor gets US FDA nod for early feasibility of its total artificial heart

    BIOPATTERN trial seeks precision approach to coronary artery disease treatment

    Inari Medical announces first patient enrolment in PEERLESS II randomised controlled trial

    Tria

    Enrolment in Indian clinical trial of Tria mitral valve completed

    First patient enrolled in RECOVER IV randomised trial of Impella in AMI patients

    AF after mitral valve surgery “has a strong negative influence on survival”

    Death rates after CABG and other surgeries “similar” regardless of patient-surgeon gender concordance

    Clinical outcomes similar at one-year for leading TAVI platforms in real-world registry, but stroke rates differ

    AI-derived risk score may improve planning of TEER for secondary mitral regurgitation

    SCAI: First US renal denervation approvals “revolutionise” treatment of uncontrolled hypertension

    Supira Medical to initiate US clinical programme for pVAD system

    Roadmap launched to guide shared decision-making in heart valve disease treatment

    Medtronic’s Symplicity Spyral renal denervation system granted US FDA approval for hypertension treatment

    JenaValve partners with American Society of Echocardiography to increase awareness of aortic regurgitation

    ARIES trial shows LVAD patients who did not receive aspirin had fewer bleeding complications

    ACCESS-MANTA registry to assess use of Manta vascular closure device in TAVI procedures

    TRANSFORM trial to explore personalised strategy for cardiovascular disease prevention

    VOYAGER

    VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations

    First-in-human study explores safety and feasibility of Captis embolic protection device during TAVI procedures

    EECP therapy results “promising” for ANOCA patients

    PATCH clinical study of PerQseal vascular closure system reaches 100-patient milestone

    First-in-human results of non-invasive ultrasound therapy for aortic stenosis published in The Lancet

    First implant of ChordArt TMVR system completed

    AHA 2023: RCE Technologies wins Health Tech competition

    SELECT trial shows cardiovascular risk reduction in non-diabetics taking semaglutide

    Xenter unveils dual-sensor TAVI guidewire

    PCI improves angina symptoms without medication in ORBITA-2 trial

    Revascularisation considered over amputation for CLTI in UK, new study states

    Medinbox launches latest proctoring and remote learning platform for cath labs

    Scott Drake appointed as Cordis CEO

    Recor Medical gains first US FDA renal denervation approval

    CONFORMAL EFS results shared out to one year at TCT 2023

    No difference in outcomes for AF patients undergoing LAAO and TAVI at the same time

    REAL-PE demonstrates statistically significant lower major bleeding rates with Ekos system compared to mechanical thrombectomy for PE treatment

    STRIKE-PE

    Late breaking STRIKE-PE data shows improved outcomes for pulmonary embolism patients

    Surmodics launches Preside hydrophilic coatings for neurovascular, coronary and peripheral applications

    E2 shares positive initial results from use of Hēlo system for acute sub-massive pulmonary embolism treatment

    First patients enrolled in coronary de novo trial of Selution SLR drug-eluting balloon

    Study provides insights from US cohort of FLASH registry for high-risk PE

    TCT 2023: TAVI system for aortic regurgitation shows promise in ALIGN AR trial

    First patients treated with Laguna Tech’s Alpha and Zeta aortic valves

    Edwards Lifesciences’ Mitris Resilia valve receives CE mark for mitral replacement surgeries

    TCT 2023: TRILUMINATE quality of life data point to benefit for patients with severe TR undergoing TEER

    TCT 2023: Initial phase of TRISCEND II trial of Evoque transcatheter replacement for severe tricuspid regurgitation meets primary endpoints

    TCT 2023: Agent DCB shows superiority to conventional balloon angioplasty for target-lesion failure in US randomised trial

    TCT 2023: Five-year PARTNER 3 results “reaffirm” role of TAVI as alternative to surgery in low-risk patients

    TCT 2023: LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough for below-the-knee arteries

    TCT 2023: Intellistent multi-lumen stent system for pulmonary arterial hypertension wins Shark Tank innovation prize

    Medinol’s EluNIR-PERL coronary stent gains US FDA approval

    TCT 2023: EVOLUT Low Risk trial shows continued strong performance for self-expanding TAVI platform out to four years

    TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the US FDA

    GE HealthCare’s Allia IGS Pulse imaging system approved by the US FDA

    RELIEF clinical study of PFO closure for migraine relief begins randomisation

    Multicentre study points to favourable safety and efficacy of radial access for peripheral interventions

    Site-less model helps to improve diversity in PREVUE-VALVE study

    Medtronic receives CE mark for Evolut FX TAVI system to treat severe aortic stenosis

    EACTS 2023: Registry study finds “significantly increased” all-cause mortality among older patients selected for TAVI versus SAVR

    OpSens and Haemonetics enter into acquisition agreement

    FEops HEARTguide LAA workflow integrated into TeraRecon software

    US FDA grants IDE approval for PROACTIVE-HF 2 study of Cordella pulmonary artery sensor

    Obituary: Roger M Greenhalgh 6th February 1941 – 6th October 2023

    EACTS 2023: On-X aortic valve “remains safe and effective with low dose warfarin”

    Elixir Medical submits approval for DynamX coronary bioadaptor in Japan

    Artivion announces meaningful all-cause mortality reduction in AMDS PERSEVERE trial

    EACTS 2023: Statin treatment may benefit SAVR patients

    Research shows “direct mechanistic link” between COVID-19 infection and heart attack, stroke

    AI

    US FDA approval for AI-powered left ejection fraction detection device

    MedAlliance acquired by Cordis

    US FDA grants conditional IDE approval for F2 cerebral embolic protection system

    Boston Scientific gains US FDA clearance for AVVIGO+ multi-modality guidance system

    Surgeons perform historic second transplant of a genetically modified pig heart into a human

    Nitrate reduces contrast-induced necropathy during coronary angiography

    Nick West appointed to associate CMO role at Shockwave Medical

    Pivotal study of ShortCut leaflet splitting device completes enrolment

    European survey highlights lack of uniformity in heart team implementation

    Updates to HyperVue intravascular imaging system approved by US FDA

    Enrolment complete in SAFE-MCS study of Early Bird bleed monitoring system

    Half of patients enrolled in SELUTION DeNovo coronary trial

    FastWave Medical secures multi-million dollar private financing within weeks

    Large annulus valve launched for transseptal mitral valve replacement system

    Ten-year NOTION trial data provide important insights on long-term TAVI outcomes and valve durability

    Watchman FLX Pro gains US FDA approval

    Enrolment begins in LOVE-DEB study of Selution SLR sirolimus-eluting balloon

    First-in-man procedure follows US FDA breakthrough designation for NyokAssist PVAD system

    ESC 2023: Study assesses impact of using Heartflow FFRCT for diagnosing coronary artery disease

    Sirolimus-eluting Orsiro stent non-inferior to zotarolimus-eluting device in BIOFLOW-DAPT trial

    Stroke expert J Mocco joins Protembis board

    Radiaction Medical secures Series C2 funding and announces board addition

    UK MHRA adds capacity for medical device certification

    ESC 2023: Prolonged clopidogrel monotherapy after PCI in high-risk ACS patients reduces bleeding and ischaemic events

    ESC and EACTS conclude review of left main revascularisation guidelines recommendations

    ESC 2023: ECLS not shown to improve survival in patients with acute MI complicated by cardiogenic shock

    ESC 2023: ADVENT trial shows PFA is non-inferior to thermal ablation for safety and efficacy in paroxysmal AF

    ESC 2023: GE Healthcare showcases latest-generation handheld ultrasound scanner and AF tool

    ESC 2023: Hot Line trials add weight to case for intravascular imaging during PCI

    ESC 2023: Siemens unveils Acuson Origin imaging platform

    FDA

    SCAI: FDA panel vote “encouraging” for advance of renal denervation

    Blood test may predict heart, kidney risk for those with type 2 diabetes

    FDA panel split on risk and benefit of Symplicity Spyral renal denervation system

    First two US patients receive Trisol tricuspid valve

    FDA panel votes favourably on safety and efficacy of Paradise renal denervation system

    ESC 2023: Risk of MI recurrence higher in patients who do not take daily aspirin

    Elevate pLVAD completes early feasibility study

    Advanced NanoTherapies secures investment for development of SirPlux Duo DCB

    SCAI position statement “aims to pave the way for renal denervation in the management of hypertension”

    Bryan Williams joins BHF as research leader

    Forxiga granted approval from China’s NMPA for treatment of symptomatic chronic heart failure

    First patient enrolled in global study of heart failure device trial

    AI model may improve detection of atrial septal defect

    Efforts needed to improve cardiovascular research in Africa

    US FDA grants de novo approval for AI-based HCM detection algorithm

    STAR-T trial of DrugSorb-ATR completed

    Xeltis secures additional €12.5 million from European Innovation Council

    Orchestra BioMed gains FDA nod to begin study of Virtue SAB sirolimus balloon

    First US implants mark start of DurAVR THV early feasibility study

    Ilika and Cirtec Medical partner on manufacture and commercialisation of Stereax solid-state batteries

    VenusP-Valve

    VenusP-Valve gains FDA authorisation for transpacific clinical study

    Canon Medical launches Alphenix / Evolve Edition angiography system in Europe

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    CMS creates new MS-DRG codes and payments for coronary IVL

    WHO adds cardiovascular polypill to essential medicines list

    TaurusTrio TAVI device gets first implants in aortic regurgitation clinical study

    Laplace Interventional secures funding for clinical testing of transcatheter tricuspid valve technology

    Tria

    First patients treated in Indian clinical trial of Tria surgical mitral valve

    Transfemoral TAVI device gains US FDA breakthrough status for aortic regurgitation

    Study confirms AI detection of HFpEF using a single echocardiogram view

    Results from studies of HeartFlow coronary technologies shared at SCCT conference

    First valve-in-valve procedure performed with DurAVR transcatheter valve

    RapidAI announces US$75 million growth investment led by Vista Credit Partners

    CardioPrecision moves into US market

    Michael Jaff joins board of directors at HeartBeam

    Clinical trial to compare PCI and CABG in women and minorities

    Extreme temperature

    Extreme temperatures and particulate pollution may increase MI mortality risk

    Global Cardiovascular Awards to recognise excellence and innovation in cardiovascular care

    Onecrea Medical announces successful first-in-human implants of Crea aortic valve

    PECA Labs appoints new board members

    SCAI welcomes FDA decision to remove red flag for use of paclitaxel-coated devices in PAD

    Ian Meredith joins board of directors at Avertix Medical

    TIMELY study will assess impact of AI platform on health of MI patients with coronary disease undergoing cardiac rehabilitation

    ESH guidelines represent a “significant milestone” for hypertension management

    INFINITY-SWEDEHEART trial of DynamX bioadaptor system completes enrolment

    Randomised trial “highly needed” to shed light on effectiveness of TAVI in bicuspid aortic stenosis patients

    Patient advocacy group says ESH guideline change will improve access to renal denervation

    HOST-IDEA sub-analysis uncovers differences in ultrathin stent platforms

    Gut bacteria linked to coronary atherosclerotic plaques

    Boston Scientific announces position on FDA update about use of paclitaxel-coated devices to treat PAD

    Approval granted to commence study of renal pelvis denervation system

    First US patients implanted with FIRE1 remote heart failure monitoring system

    Long-awaited US FDA update finds data do not support excess mortality risk for paclitaxel-coated devices

    First patient enrolled in MOJAVE study of DSR 2.0

    Alvimedica launches Kaplan curves radial portfolio for diagnostic procedures

    Streamlined TAVI pathway paves the way for same-day discharge “record”

    Researchers develop flexible bioresorbable monitor for cardiac patients

    “World’s first” dual chamber leadless pacemaker system granted US FDA approval

    Medtronic heralds ESH guidelines as a “turning point” for renal denervation

    SonieVie

    Combination of chronic kidney disease and diabetes associated with a higher rate of death or MI among women undergoing PCI

    Minimum level of oxygen required during cardiopulmonary bypass “may be lower than previously thought”

    Translumina acquires Blue Medical Devices

    ALL-RISE study of CathWorks FFRangio system enrols first patient

    heart attack

    Depressed ICD patients “more likely to stop medications”

    New arterial hypertension guidelines update recommendations on the use of renal denervation

    AI

    ECG-AI algorithm for early identification of amyloidosis gains US FDA breakthrough designation

    Vygon to manufacture vascular outflow tract for Aeson artificial heart

    Black patients nearly 50% less likely to receive revascularisation for PAD

    iTFlow blood flow analysis software gains US FDA approval

    CorWave closes series C funding round

    egnite and JenaValve partner to assess prevalence of aortic regurgitation in USA

    heart attack

    Anxiety affects high proportion of patients with an ICD

    CHOP physicians conduct first-in-human implant of MASA polymeric pulmonary valve

    Pacing wire for TAVI and balloon aortic valvuloplasty procedures gains US FDA clearance

    STEMI patients “lose years of life” due to care delays during COVID-19 lockdowns

    EuroPCR 2023: Biolimus-coated balloon fails to match paclitaxel for in-stent restenosis

    AI

    US FDA approval for AI TAVI planning software

    ESC appoints Jean-François Riffaud as CEO

    Translumina extends European reach with Lamed acquisition

    FDA

    US FDA seeks to “modernise” clinical trials with new draft guidance

    New study elucidates exact location of atherosclerotic plaque ruptures in carotid arteries

    Research highlights “strikingly low” use of public defibrillators in cardiac arrest

    Lars Søndergaard joins Abbott’s structural heart business

    Conformal Medical completes series D financing round

    First TAVI procedures performed using F2 cerebral embolic filter

    Amazon executive joins Medtronic to spearhead development in robotics and implantables

    First-in-man implant of “modular” TAVI device performed in Israel

    MONITOR-HF trial results show improvement in quality of life scores for heart failure patients with CardioMEMS system

    Artificial intelligence could enable life-saving early diagnosis and advance the treatment of pulmonary hypertension

    Proprietary antioxidant complex shown to safeguard DNA from radiation exposure during aortic procedures

    Early anticoagulation after ischaemic stroke “reasonable” and “unlikely to cause harm”

    SCAI 2023: Similar revascularisation rates seen with ticagrelor monotherapy and DAPT in TWILIGHT trial

    HRS 2023: BIO-LIBRA study offers insights into device treatment of non-ischaemic cardiomyopathy

    HRS 2023: SOLVE-CRT results “offer new hope for patients with hard-to-treat heart failure”

    TVT registry analysis finds close to 90% success in mitral TEER procedures

    AI

    HRS 2023: Researchers hope to use AI to “revolutionise” prediction of sudden cardiac death

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    Cardiovascular News

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