A single-centre real world experience has found that the vast majority of patients with severe mitral regurgitation (MR) were not eligible for inclusion in the COAPT trial, with the most frequent reason for exclusion being that they were not...
Over the past few years, the indications for transcatheter aortic valve implantation (TAVI) have expanded from inoperable patients to low-risk patients—meaning that TAVI can now be considered for all aortic stenosis patients, regardless of their surgical risk.1 However, using...
The mortality risk for patients with critical limb ischaemia (CLI) has not changed over the last few decades, despite advances in cardiovascular medicine that treat myocardial infarction and stroke, the two biggest causes of death in these patients, Sahil...
Shockwave Medical has initiated the DISRUPT CAD IV study of its intravascular lithotripsy (IVL) system with the aim of using data from the study to support regulatory device approval in Japan. The system is used in the management of...
A wrist-based optical blood pressure monitor has the potential to replace cuff monitoring systems for ambulatory blood pressure, suggests a study in the journal Blood Pressure Monitoring. A press release from Aktiia, the Swiss-based company manufacturing the device, states...
The use of multiphase computed tomography (CT) assessment, particularly during the early systolic phase, of the neo-left ventricular outflow tract (LVOT) is a better predictor of clinically relevant obstruction in transcatheter mitral valve replacement (TMVR) than end systole measurements....
A prespecified subgroup analysis of the GLOBAL LEADERS trial has found no between-sex difference in the risk of two-year all-cause mortality or new Q-wave myocardial infarction (MI) following percutaneous coronary intervention (PCI). Published online in JAMA Cardiology, the study...
Left atrial appendage closure (LAAC) via implanted device was associated with a decreased risk of admission for stroke, compared with the expected risk without anticoagulation therapy, according to a study published in the Journal of the American Medical Association...
Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients, the first TAVI company to have this indication in Europe. Both Edwards...

Ehtisham Mahmud

The 2019–20 president of the Society for Cardiovascular Angiography and Interventions (SCAI) Ehtisham Mahmud (division chief, Cardiovascular Medicine, UC San Diego, San Diego, USA) tells Cardiovascular News about his career highlights, and outlines the key priorities for his presidency. 1....
Patients who have mixed aortic valve disease with pre-existing aortic regurgitation have better survival rates following transcatheter aortic valve implantation (TAVI) than those who have aortic stenosis alone. Writing in JACC: Cardiovascular Interventions, Johnny Chahine (Cleveland Clinic, Cleveland, USA)...
CorFlow Therapeutics has announced that the company has been granted Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Controlled Flow Infusion (CoFI) System. It is indicated for the diagnostic assessment of the coronary microcirculation...
Cardionovum's Restore paclitaxel-coated balloon for coronary applications has received market approval for use in China. It can be used in treating two indications: in-stent restenosis and small vessel disease. A joint press release from Cardionovum and China Grand Pharmaceutical...
The stockholders of Corindus Vascular Robotics have approved the adoption of the agreement and plan of merger that was drawn up in August by Siemens Medical Solutions USA (Siemens Healthineers), Corpus Merger, and Corindus. A press statement reports that, subject...
Further evidence for a shorter duration of dual antiplatelet therapy (DAPT) in patients implanted with a drug eluting stent has been provided with the presentation of two studies at Transcatheter Cardiovascular Therapeutics (TCT 2019; 24–29 September, San Francisco, USA). Data...
Using optical coherence tomography (OCT)-to guide percutaneous coronary intervention (PCI) is associated with a lower occurrence of major adverse cardiac events (MACE) or significant angina in patients with angiographically-intermediate coronary lesions (AICL) than fractional flow reserve (FFR)-guidance. However, FFR...
Different strategies are needed to address the continuing lack of diversity in the US cardiology workforce, say the authors of a cross-sectional study which found that numbers of underrepresented minority individuals and women remain proportionately lower, and that progress...
A study published as a research letter in JAMA Internal Network has found a “substantial misclassification” of patient deaths for the Sapien 3 and MitraClip devices in the US Food and Drug Administration (FDA) database which, the authors say,...
Clinical data presented at the 2019 European Cardio-Thoracic Surgery (EACTS) annual meeting (3-5 October, Lisbon, Portugal), from two prospective trials of the VEST external stent for vein grafts during coronary artery bypass surgery (CABG), showed low major adverse cardiac...
The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) recommending the use of Xarelto (rivaroxaban) by the National Health Service (NHS) in England at a dose of 2.5mg twice daily combined with...
Shockwave Medical, a company which provides intravascular lithotripsy (IVL) to treat complex calcified cardiovascular disease, unveiled the results of the DISRUPT CAD II study, a European postmarket study of coronary IVL, in a High Impact Clinical Research session at...
William W Pinsky and Mandeep R Mehra explain to Cardiovascular News how international medical graduates contribute to both their adopted country and their country of origin, providing benefits for all. It should come as no surprise that international medical graduates...
This content is only for readers outside of the US as it discusses a device that is not FDA approved. The PASCAL repair system (Edwards Lifesciences, Irvine, CA, USA) is a novel leaflet repair therapy. The implant uses clasps and...
During a session on radiation protection technologies at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25­–29 September, San Francisco, USA), Lloyd W Klein (Rush Medical College, Chicago, USA) said that Henry V led the heavily outnumbered English army to victory at...
Admedus has sold the distribution rights to its CardioCel and VascuCel product range for $A36.2 million to US-based LeMaitre Vascular. A press release from Admedus announces that it will focus on advancing its transcatheter aortic valve implantation (TAVI) programme...
Penumbra has announced the enrolment of the first patient into the CHEETAH study, a prospective, multicentre US study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in coronary vessels. A press release from...
Douglas Drachman has been selected as the next vice chair of the American College of Cardiology’s Annual Scientific Session. Drachman will serve as vice chair for two years, at ACC ‘21 and ACC ‘22, and then as chair for...
Cardiothoracic surgeon David Taggart (Department of Cardiac Surgery, University of Oxford, John Radcliffe Hospital, Oxford, UK) told delegates attending the 2019 European Association for Cardio-Thoracic Surgery (EACTS) meeting (3–5 October, Lisbon, Portugal) that the definition of myocardial infarction used...
Abiomed has announced the results of PROTECT III, an ongoing, prospective, single-arm US Food and Drug Administration (FDA) post-market approval (PMA) study for Impella 2.5 and Impella CP in high-risk percutaneous coronary intervention (PCI). PROTECT III follows the PROTECT...
Data from an interim analysis of heart failure patients treated in the CorCinch FMR study show, a press release reports, that the AccuCinch ventricular repair system (Ancora Heart) is associated with a favourable safety profile, with 97% freedom from...
A prespecified analysis of data from the AUGUSTUS study, released at late-breaking session at the Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2019; 25–29 September, San Francisco, USA) and published online in Circulation, indicate that anticoagulation with apixaban and a...
The Gore Cardioform Occluder for atrial septal defects (ASD) has received CE mark in Europe, the company has announced, stating that the move was supported by data from the Gore ASSURED clinical study. In its press release, Gore points out...
Interest in transseptal puncture has surged with the development of structural interventions for the left side of the heart. Francesco Maisano provides an update on its changing role in modern interventional cardiology. The transseptal puncture (TP) technique was developed in...
Endotronix has announced the expansion of its series D financing round, bringing the total to US$70 million. The expansion syndicate includes new investment from an additional unnamed medical device strategic investor, as well as participation from existing investors. The...
ONYX ONE, the first randomised trial to compare a durable polymer drug-eluting stent to a polymer-free drug-coated stent in patients at high risk of bleeding and treated with one-month dual antiplatelet therapy (DAPT), has found that both are clinically...
A subanalysis of PARTNER 3 quality of life data demonstrated a modest, but significant, improvement in one-year disease-specific quality of life after transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in low-risk patients with severe...
A timing substudy of the COMPLETE trial has found that, compared with culprit-lesion only percutaneous coronary intervention (PCI), a strategy of non-culprit lesion PCI with the goal of complete revascularisation performed early during index hospitalisation (median one day) or...
The MitraClip device (Abbott) continues to demonstrate safety and efficacy at three years in patients with heart failure and secondary mitral regurgitation (MR), findings from the COAPT trial have shown. In addition, patients who crossed over and received the...
The first randomised trial to compare the safety and efficacy of the Acurate neo transcatheter heart valve (Boston Scientific) with the Sapien 3 TAVI device (Edwards Lifesciences) did not meet non-inferiority in patients with severe aortic stenosis. The findings were...
The Portico IDE study has found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve implantation (TAVI) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to...
Data from the TWILIGHT study demonstrate that, compared to ticagrelor plus aspirin, ticagrelor monotherapy reduces bleeding events without increasing the risk of death, myocardial infarction, or stroke in high-risk patients who have undergone successful percutaneous coronary intervention (PCI) and...

FDA approves Evolut PRO+

The US Food and Drug Administration (FDA) has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds off the proven self-expanding, supra-annular Evolut TAVI platform. The press release adds that the Evolut...
In our September issue, we report on the top stories from the 2019 European Society of Cardiology (ESC) congress (31 August–4 September, Paris, France). This includes COMPLETE, ISAR-REACT 5, and BIOSTEMI. We also profile Ehtisham Mahmud.
In our September issue, we report on the top stories from the 2019 European Society of Cardiology (ESC) congress (31 August–4 September, Paris, France). This includes COMPLETE, ISAR-REACT 5, and BIOSTEMI. We also profile Ehtisham Mahmud.
The August issue of Cardiovascular News covers the top stories from EuroPCR 2019, looking at PCR statements on TAVI. We also review stakeholders' response to the updated CMS coverage for TAVI and profile Josep Rodes-Cabau.
The August issue of Cardiovascular News covers the top stories from EuroPCR 2019, looking at PCR statements on TAVI. We also review stakeholders' response to the updated CMS coverage for TAVI and profile Josep Rodes-Cabau.
Ashok Seth (New Delhi, India) talks to BLearning at EuroPCR 2019 (21–24 May, Paris, France) about the MyVal-1 study which looked at the one-year clinical outcomes of India’s first indigenously designed and manufactured TAVR system. This was the first in-human study of the device...
Boston Scientific has announced the key data that will be presented at the Transcatheter Cardiovascular Therapeutics conference (TCT 2019; 25–29 September, San Francisco, USA). Data from the EVOLVE Short DAPT study, evaluating the safety of early dual antiplatelet therapy discontinuation...
Corindus Is to showcase the CorPath GRX system at the Transcatheter Cardiovascular Therapeutics Conference (TCT 2019; 25–29 September, San Francisco, USA). CorPath GRX is the only US Food and Drug Administration (FDA) cleared and CE-marked medical device for robotic-assisted...
Abbott has announced its TRILUMINATE pivotal trial to evaluate the safety and effectiveness of the TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation. This is the first pivotal Investigational Device Exemption (IDE) trial in...
AtriCure has entered into a definitive agreement to acquire SentreHEART, which developed the LARIAT device for left atrial appendage closure in patients with atrial fibrillation. A press release reports that the transaction consideration consists of an upfront payment of...
Martin Kostelka (Leipzig, Germany), who was the first to use the CardioCel 3D (Admedus) product after it was recently CE marked in Germany, talks to Cardiovascular News about his experience where he implanted the 3D scaffold in a small child, a...
Caution: This content is only for readers outside of France and Japan. In the US, ACURATE neo is limited by U.S. law to investigational use only. Not available for sale. Since the first implant 17 years ago, transcatheter aortic valve...
Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the Medtronic Board of Directors has announced key leadership appointments as part of its multi-year, leadership...
A new study indicates that the Meridian transcatheter aortic valve implantation (TAVI) valve (HLT) is associated with a 30-day mortality rate of 8% and a six-month mortality rate of 12%. The valve is fully retrievable after deployment, which allows...
Merit Medical Systems, a leading manufacturer and marketer of proprietary devices used primarily in cardiology, radiology, oncology, and endoscopy, has announced the commercial launch of the PreludeSYNC EVO radial compression device in the USA. PreludeSYNC EVO is a sterile,...
Virtual patient care is creating exciting learning opportunities for interventional cardiologists. Atman P. Shah considers how training through gaming can deliver a state-of-the-art profession. Recently, I was between patients, with a few minutes to spare. I opened an app on...
New data from the SwedeHF heart failure registry indicates that the use of an implantable cardioverter defibrillator (ICD) in patients with heart failure with reduced ejection fraction (HFrEF) is associated with a significant reduction in all-cause mortality at both...
At the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France), Jean-Francois Obadia (Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Lyon, France) reported that the two-year results of MITRA-FR indicate that percutaneous edge-to-edge repair...
One-year data from the BIOSTEMI study, simultaneously published in The Lancet and presented at the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France), indicate that patients with ST-segment elevation myocardial infarction (STEMI) who undergo percutaneous...
Speaking to Cardiovascular News at the ECHSA 2019 meeting (European Congenital Heart Surgeons Association; 20–22 June; Sofia, Bulgaria), Guido Michielon (London, UK) says that the CardioCel bioscaffold (Admedus) has a wide application from neonatal age to paediatric age. The main advantage is that...
This morning at the 2019 European Society of Cardiology (ESC) Congress (31 August–4 September, Paris, France), Pavel Osmancik (Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic) presented the results of PRAGUE-17. These showed that left atrial appendage...
A strategy of complete revascularisation was superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing the risk of cardiovascular death or myocardial infarction (MI) in patients with ST-segment myocardial infarction (STEMI) and multivessel coronary artery disease. The timing...
Stefanie Schüpke (Deutsches Herzzentrum München, and Technische Universität München, Munich, Germany) told ESC delegates today that using prasugrel rather than ticagrelor to treat patients with acute coronary syndromes is associated with a significant reduction in the incidence of death,...
At the 2019 European Society Cardiology (ESC) congress (31 August – 4 September, Paris, France), Abiomed revealed that its Impella CP with SmartAssist technology is now commercially available in Europe. A press release reports that the system is designed to...
Giovanni Stellin (Padova, Italy) talks to Cardiovascular News at the ECHSA 2019 meeting (European Congenital Heart Surgeons Association; 20–22 June; Sofia, Bulgaria) about his own experience with the CardioCel (Admedus) bioscaffold which he found “excellent in reconstructing part of the heart in small...
Although renal denervation may not hit the heights originally envisaged for it in the management of hypertension, and areas of uncertainty remain, Partha Sardar and Herb Aronow explain why they believe that it has the potential become a mainstream...
A polypill that combines four cardiovascular drugs has been shown to reduce the risk of major cardiovascular events in the general population when taken in a low-dose once-daily. Findings from the PolyIran study, a five-year randomised controlled trial, were...
AstraZeneca has announced positive results from the Phase III DAPA-HF trial which showed that FARXIGA (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation...
CeloNova has announced the appointment of Carl J St. Bernard as president and chief executive officer (CEO). According to CeloNova, St. Bernard joins the company from Tryton Medical where he was president and CEO, leading the company’s commercialisation efforts in...
The US Food and Drug Administration has approved the Barostim Neo system for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronisation therapy....
Horst Sievert (Frankfurt, Germany) talks to BLearning at EuroPCR 2019 (21–24 May, Paris, France) about the VECTOR-HF trial which evaluated the safety, usability and performance of a novel wireless pressure monitoring system in adult patients with New York Heart Association (NYHA) Class III Heart Failure...
According to a BIBA MedTech survey, 52% of neurointerventionalists believe that they are the only specialists who have the relevant skills and experience to perform interventional stroke procedures (e.g. mechanical thrombectomy). However, of those who believe other specialities—with the appropriate...
On 16 August, the US Food and Drug Administration (FDA) approved Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s Evolut R and Evolut PRO transcatheter aortic valve implantation (TAVI) systems for the management of low-risk patients. However,...
Edwards Lifesciences—in a press statement announcing its global second quarter (Q2) financial results—has revealed that it is taking the self-expanding transcatheter aortic valve implantation (TAVI) device Centera off the market. The company says resources will instead be focused on...
The Cardiovascular Research Foundation (CRF) has announced the 12 late-breaking trials and 16 late-breaking science presentations that will be reported at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 scientific symposium. TCT, the world’s premier educational meeting specialising in interventional cardiovascular...
The Myval transcatheter aortic valve implantation (TAVI) system, designed and manufactured by Meril Lifesciences in India, recently received the CE mark for the management of severe aortic stenosis. In this commentary, Ashok Seth discusses his experience with the Myval...
 Tomasz Mroczek (Kraków, Poland) talks to Cardiovascular News at ECHSA 2019 (European Congenital Heart Surgeons Association, 20 – 22 June, Sofia, Bulgaria) – where the management of critically ill infants was a hot topic – about using CardioCel (Admedus)...
Cardiovascular Systems recently announced that it has acquired the Wirion embolic protection system and related assets from Gardia Medical. The device, which received CE Mark in June 2015 and US Food and Drug Administration (FDA) clearance in March 2018, is...
Data from two new studies suggest that transcatheter tricuspid valve repair (TTVr) is a safe and effective treatment option for patients with symptomatic or severe tricuspid regurgitation (TR) who are not suitable for surgery. Both were published in JACC:...
Hormone replacement therapy is a common treatment for menopause-related symptoms, and new research from the University of Pittsburgh Graduate School of Public Health (Pittsburgh, USA) reinforces the importance of tailoring hormone therapy to each patient, based on her individual risk...
B Braun Interventional Systems has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR). SeQuent Please ReX is...
The National Institute for Health and Care Excellence (NICE) in the UK has published a positive draft final appraisal determination recommending the use of rivaroxaban (brand name Xarelto, Bayer) by the National Health Service (NHS) in England. The NICE...
Ulrich Schäfer (Hamburg, Germany) speaks to Cardiovascular News at EuroPCR (21–24 May, Paris) about the VIVALL study which looked at the safety and efficacy of the replacement of failed surgical bioprosthetic aortic valves with the Allegra Transcatheter Heart Valve...
Caner Salih (London, UK) talks to Cardiovascular News about the CardioCel bioscaffold (Admedus) and the benefits it has brought to his practice at Guy's and St Thomas’ hospital. According to Salih, CardioCel has become the “tissue of choice” and he...
The clinical frailty score currently used to assess suitability for transcatheter aortic valve implantation (TAVI) requires further refinement, a study published in the American Journal of Cardiology has concluded. However, the investigators also say that patients aged ≥90 years...
Patients whose prescription for PCSK9 inhibitors (proprotein convertase subtilisin kexin type 9 inhibitors) are either unfilled or rejected by insurance companies have a higher rate of cardiovascular events than those whose prescriptions are paid for. Kelly D Myers (The...
Recent low-risk trials for TAVI look set to expand its indications for use. Amar Krishnaswamy and Samir Kapadia assess the impact of the findings on everyday practice, and look at areas where uncertainties remain. Transcatheter aortic valve implantation (TAVI) is...
Medtronic has entered into a partnership agreement with Viz.ai to accelerate the adoption of artificial intelligence software for stroke prevention and treatment in US centres. A press release from Medtronic announced the collaboration, describing Viz.ai as “the emerging leader...
The first patient has been randomised in the TARGET BP I trial at the Piedmont Heart Institute in Atlanta, USA, to investigate the use of the Peregrine System Kit (Ablative Solutions) in renal denervation. Target BP I is a blinded,...
Edwards Lifesciences has announced it has made the “difficult decision” to discontinue its self-expanding transcatheter aortic valve implantation (TAVI) device Centera. The company says the resources required to “optimise deliverability as well as expanding the indications to match the...
Edwards Lifesciences has issued an urgent safety notice for the latest generation of its Sapien device, Sapien 3 Ultra, after it received reports of “burst balloons, which have resulted in significant difficulty retrieving the Sapien 3 Ultra delivery system...
According to a statement, Abbott has announced it has received US Food and Drug Administration (FDA) approval for the fourth-generation MitraClip heart valve repair device to treat mitral regurgitation. The latest approval for MitraClip G4, puts new enhancements into...
Women who suffer from idiopathic intracranial hypertension (IIH) have twice the risk of heart conditions and stroke than those of the same age and body mass index (BMI) who do not have IIH, a study published in JAMA Neurology...
Five-year results suggest that surgical aortic valve replacement (SAVR) is associated with lower rates of mortality and major adverse cardiac and cerebrovascular events (MACCE) than transfemoral transcatheter aortic valve replacement (TAVI) performed using first-generation devices in low- and intermediate-risk...
Speaking to Cardiovascular News at EuroPCR 2019 (21–24 May, Paris, France), Georg Nickenig (Bonn, Germany), discusses the results of the TRILUMINATE trial which looked at the safety and efficacy of treating tricuspid regurgitation with a novel tricuspid valve repair...
Thanks to the use of robotics in healthcare, many procedures that were once highly invasive are now being performed using minimally invasive techniques, with the added benefits of precision and radiation protection. Jean Fajadet looks at how the technology...
  Cardiac Dimensions has announced in a press release that its Carillon Mitral Contour System has now been implanted in 1,000 patients in the USA, Europe, Australia, Turkey, and the Middle East. The Carillon System is a right-heart transcatheter mitral...
  Medtronic has announced plans for a global registry of its HeartWare HVAD System, following the release of two-year outcomes from the LATERAL clinical trial. The HVAD System is a left ventricular assist device (LVAD) that helps increase the amount...
FEops has won the CSI Frankfurt 2019’s Highlight of the Year Award for its FEops HEARTguide under the category of interventional imaging. A press release reports that this award celebrates promising technologies that will have the biggest impact in...
After receiving reports of difficulty tracking and manipulating the Centera transcatheter aortic valve implantation (TAVI) system around the aortic arch, Edwards Lifesciences has issued an urgent safety notice. The notice states that these difficulties have “resulted in vascular injury...
The Liverpool Centre for Cardiovascular Science, an alliance between academia and the NHS, was established to advance cardiovascular and stroke research and innovation locally, nationally, and internationally. The director of the centre, Professor Gregory YH Lip, Price-Evans chair of...
Data from the MeRes-1 and MeRes-1 Extend clinical trials, released at EuroPCR 2019 (20–24 May, Paris, France), demonstrate sustained efficacy and safety for the recently CE-approved MeRes100 (Meril) bioresorbable scaffold (BRS). A press release from Meril describes it as a...
Admedus has announced positive data from an independent study into the performance of its tissue engineered bovine pericardial implant CardioCel, which is used in the repair of congenital heart defects in children. Published in The Annals of Thoracic Surgery, the...
PASCAL’s (Edwards Lifesciences) safety and efficacy may rival that of MitraClip (Abbott) for the treatment of mitral regurgitation (MR), according to data published in JACC: Cardiovascular Interventions. Fabien Praz, Stephan Windecker (University Hospital Bern, Bern, Switzerland), and Samir Kapadia...
The National Institute for Health and Care Excellence (NICE) has released evidence-based recommendations on the percutaneous insertion of a cerebral protection device to prevent cerebral embolism during transcatheter aortic valve implantation (TAVI). It says that the evidence on percutaneous insertion...
Zoll Medical, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, has acquired TherOx—a company on improving treatment of acute myocardial infarction and markets systems to deliver super saturated oxygen (SSO2) therapy. A press release reports...
Valix Medical has received a US patent—10,278,820 (percutaneous valve repair and replacement)—for its heart valve repair and replacement technology. A press release reports that the company is developing transcatheter solutions for patients suffering from valvular heart disease and heart...
Robocath has announced that that the well-known interventional cardiologists Michael Haude, Faziel Lorgat, and Holger Nef have joined its medical advisory board. Founded in 2009 by Philippe Bencteux, Robocath designs, develops and commercializes robotic solutions to treat cardiovascular diseases;...
A Philips press release reports both the EPIQ CVx and EPIQ CVxi now include automated applications for 2D assessment of the heart, as well as robust 3D right ventricle volume and ejection fraction measurements—with the aim of making accurate...
One-year data for the Myval transcatheter aortic valve implantation (TAVI) system indicate it is associated with 100% freedom from device related mortality at one year. These data, which were presented at EuroPCR 2019 (21–24 May, Paris, France) also showed...
Siemens Healthineers and Mentice have announced a collaboration to fully integrate Mentice’s Vist “Virtual Patient” into the Artis icono angiography system from Siemens Healthineers. A press release reports that the Vist Virtual Patient, thus, becomes a fully integrated simulation...
New data show that the use of the investigational HeartFlow Planner—a real-time, non-invasive interactive planning tool—led to a change in treatment strategy in 45% of patients with coronary artery disease and reduced the need for invasive physiology. The data from the...
Royal DSM is to collaborate with Strait Access Technologies (SAT) to develop the world’s first durable and cost-effective transcatheter replacement heart valves with polymeric leaflets. This collaboration is initially focused on developing valves to treat rheumatic heart disease. A press...
The Centers for Medicare & Medicaid Services (CMS) has finalised its update the US coverage for transcatheter aortic valve implantation (TAVI). It will continue to provide coverage with evidence development when furnished according to an FDA-approved indication. However, it...
The OPTION trial is to compare the compare safety and effectiveness of the next-generation Watchman FLX left atrial appendage closure platform with first-line oral anticoagulants—including direct oral anticoagulants and warfarin—for stroke risk reduction in patients with non-valvular atrial fibrillation...
A company providing what a press release calls “next-generation electrophysiology technology solutions” has announced that it now has US$170m financing. The press release reports that this includes a US$100 million Series D equity financing and a US$70 million credit...
2019 saw the 30th anniversary of EuroPCR, with 11,206 participants gathering in Paris. William Wijns, PCR chair, shares his perspective on how it has evolved since 1989 and the reasons for its success, and explains why healthcare professionals should...
The Society for Coronary Angiography (SCAI) has issued a statement, endorsed by the Alliance of Cardiovascular Professionals (ACVP), providing advice on the economics of cardiovascular cath labs and how they can be financially viable. The aim of the document is...

Adrian Banning

Adrian Banning (John Radcliffe Hospital, Oxford, UK) initially wanted to fly a Boeing 747 but, aged nine, decided go into medicine instead. He talks to Cardiovascular News about his involvement in both the SYNTAX and the SYNTAX 2 trials,...
New data for the PASCAL system (Edwards Lifesciences), which received the CE mark in February 2019 for the management of mitral regurgitation, suggest it may have a role in the management of tricuspid regurgitation. During the first-ever late-breaking trial...
Speaking during an innovation session at TVT 2019 (12-15 June, Chicago, USA), Mark Hensey (Centre for Heart Valve Innovation, St Paul's Hospital, University of British Columbia, Vancouver, Canada) outlined the early experience with a purpose-designed temporary pacing guidewire (Wattson,...
This morning at TVT 2019 (12-15 June, Chicago, USA), in separate presentations, the principal investigators of PARTNER 3 and Evolut Low Risk trials both said that the findings of the studies indicate that transcatheter aortic valve implantation (TAVI) should...
Orchestra BioMed and Terumo have formed a global strategic partnership for the development and commercialisation of Virtue sirolimus-eluting balloon (SEB) in the percutaneous coronary and peripheral interventions field. Virtue SEB is the first and only non-coated drug-eluting angioplasty balloon that...
Cardiologists can help to reduce the threat of nuclear war and move “the hands of the Doomsday Clock back from the midnight hour”, according to an opinion piece published in Circulation. James E Muller (Brigham and Women’s Hospital, Boston,...
Evolving indications for the use of transcatheter aortic valve implantation (TAVI) have led to a series of “paradigm shifts” in the treatment of severe symptomatic aortic stenosis, according to a position statement issued by PCR, which says that TAVI...
The Helix biotherapeutic delivery system (Biocardia), which delivers cell therapy to patients within four weeks of a heart attack, led to improved ejection fraction and fewer symptoms (improved by >one New York Heart Association class), according to data...
A press release from Biotronik highlights data from the BIOSOLVE-IV registry outlining procedural success and a positive safety profile at one year for its Magmaris Resorbable Magnesium Scaffold (RMS) device. The target lesion failure (TLF) rate at 12 months was...
The Cardioform ASD Occluder (Gore Medical) has received US Food and Drug Administration (FDA) premarket approval (PMA) for use in the percutaneous closure of ostium secundum atrial septal defects (ASDs). A press release from the company says that the...
Alex Rothman (Sheffield, UK) discusses the TROPHY1 study which looked at the safety and efficacy of ultrasound pulmonary artery denervation in patients with pulmonary arterial hypertension (PAH). Rothman says that best medical therapy provides benefits but that “patients continue...
The American College of Cardiology (ACC) has announced the appointment of Ranna Parekh as its first director of diversity and inclusion. Parekh will work with the ACC Task Force on Diversity and Inclusion and other societies and organisations to...
This content is only for readers outside of the US as it discusses a device that is not FDA approved. On February 12, 2019, Edwards Lifesciences received the CE mark for its PASCAL transcatheter valve repair system for managing mitral...
Thomas Modine (Lille, France) talks to Cardiovascular News about the PARTNER 3 trial comparing low-risk patients who had a transcatheter aortic valve replacement (TAVR) compared with those who underwent surgical aortic valve replacement (SAVR). The PARTNER 3 findings showed that...
Royal Philips recently announced the launch of the new IntraSight interventional applications platform. According to a press release, the secure, application-based platform offers a comprehensive suite of clinically proven iFR, FFR, IVUS and co-registration modalities to simplify complex interventions...
According to a press release, Boston Scientific has initiated the OPTION trial to compare safety and effectiveness of the next-generation Watchman FLX left atrial appendage closure platform to first-line oral anticoagulants (OAC)—including direct oral anticoagulants (DOAC) and warfarin—for stroke...
Medtronic recently announced the global launch of the Telescope guide extension catheter, a newly designed catheter used to provide additional backup support and access to distal lesions. Guide extension catheters help deliver coronary stents, balloons and other interventional devices...
Early experience with the Allegra transcatheter heart valve (New Valve Technology) suggests it is safe for use in patients who have clinically significant degenerated bioprostheses in the aortic position, performing as intended on 30-day outcomes in the VIVALL pilot...
Use of a TriClip (Abbott) for edge-to-edge repair in patients with tricuspid regurgitation appears to be a safe procedure, according to 30-day data from the TRILUMINATE clinical trial which were presented at EuroPCR 2019 (20–24 May, Paris, France). In...
PCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) issued a statement at EuroPCR 2019 (20–24 May, Paris, France) outlining the role of percutaneous edge-to-edge repair in the management of heart failure and secondary mitral regurgitation. Bernard Prendergast (St....
Data presented at EuroPCR today indicates that renal denervation with the Symplicity system (Medtronic) is associated with a reduction in subclinical atrial fibrillation in high-risk patients with hypertension over a median follow-up of two years. In the study, 80 patients...
Late-breaking trial data presented at EuroPCR 2019 (20–24 May, Paris, France) on three year outcomes of a substudy of patients with small vessel disease in the BIORESORT randomised controlled trial demonstrate significantly lower target lesion revascularisation rates for the...
A consensus paper on the use of intracoronary imaging was released at EuroPCR 2019 (20–24 May, Paris, France) as a joint document with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). It aims to provide the interventional community with...
In our latest edition, new evidence for the use of transcatheter aortic valve implantation (TAVI) in low-risk patients is discussed. While we profiled Adrian Banning, Omar Chehab contributes, as he explores the implications of COAPT.  
In our latest edition, new evidence for the use of transcatheter aortic valve implantation (TAVI) in low-risk patients is discussed. While we profiled Adrian Banning, Omar Chehab contributes, as he explores the implications of COAPT.  
Using the diastolic pressure ratio (dPR) to identify ischaemia-producing lesions in patients with coronary artery disease provides a similar diagnostic performance to the instantaneous wave-free ratio (iFR). A pooled analysis of pre-recorded pressure tracings from the diagnostic accuracy studies...
ClearFlow medical device company has announced positive clinical trial results for its PleuraFlow device, presented at the American Association for Thoracic Surgery (AATS) 99th Annual Meeting on (4–7 May, Toronto, Canada). The company also announced inclusion in the new...
A Scientific Statement from the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology has called for greater use of home-based cardiac rehabilitation as a secondary prevention tool in the USA...
Shockwave Medical has appointed Keith D Dawkins as its chief medical officer. In a press release from the company, Dawkins states: “Given the challenges associated with treating calcium throughout the cardiovascular system, joining Shockwave and contributing to the development...
The AVANCE steerable introducer product family (BioCardia) has received US Food and Drug Administration (FDA) 510(k) clearance. The AVANCE device is designed to introduce various cardiovascular catheters into the heart, including via the left side of the heart through...
Cordis, a Cardinal Health company, has announced the full US launch of its Radial 360 portfolio, offering a complete range of products to facilitate the transradial approach (TRA) for interventional cardiology procedures. The transradial approach uses the radial artery...
Abiomed has announced an expanded US Food and Drug Administration (FDA) approval for the Impella 5.0 and Impella LD heart pumps premarket approval (PMA) labelling in the treatment of cardiogenic shock, extending the duration of support for each pump...
  The transfemoral approach is—by far—the most desirable access route for transcatheter aortic valve implantation (TAVI) for eligible patients; it was used in the TAVI arm of the recently published PARTNER 3 trial, showing superiority over surgical aortic valve replacement...
Nearly two thirds (64.3%) of cath lab staff believe that the financial/administrative burdens of meeting percutaneous coronary intervention (PCI) public reporting requirements are not outweighed by the potential benefits in terms of improving quality of care. Furthermore, the median...
Current US guidelines recommend the use of embolic protection during saphenous vein graft percutaneous coronary intervention (PCI) but, according to a new study, embolic protection is only used in 37.9% of cases with a significant decrease over time. Furthermore,...
Patients with ST segment elevation myocardial infarction (STEMI) who undergo percutaneous coronary intervention (PCI) should be triaged for intensive care (ICU) treatment based on risk factors that include reperfusion delay to avoid overuse of ICU facilities. A review of...
Ortho Clinical Diagnostics has received the CE mark for its next-generation Vitros high sensitivity troponin I assay. A press release reports that this new assay is the latest addition to the company’s robust cardiology menu and is a critical...
NeoChord has announced that it has secured additional funding as an extension of its Series D equity financing, which was announced in November of 2018. The additional funds bring the total equity that NeoChord has raised in the past...
Biotronik has launched the PK Papyrus covered coronary stent system in the United States for use in the emergency treatment of acute coronary perforations. PK Papyrus is the first Food and Drug Administration (FDA)-approved device for the treatment of...
The Virtue (Orchestra BioMed) sirolimus-eluting balloon for the treatment of coronary in-stent restenosis has secured breakthrough device designation from the US Food and Drug Administration (FDA). Breakthrough designation for a medical device or a device-led combination of products enables manufacturers...
Bardy Diagnostics, provider of ambulatory cardiac monitoring technologies and custom data solutions, has announced it has raised $35.5 million (US) in Series B funding, which it will use to further accelerate growth of its P-wave focused cardiac monitoring platform...
Boston Scientific has received US FDA approval for its Lotus Edge transcatheter aortic valve implantation (TAVI) system. It is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart...
TherOx has received US FDA premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. A press release reports that SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle...
Tioga Medical—a newly formed Shifamed portfolio company—has announced the closing of its series A preferred stock financing, raising a total of US$15M. According to a press release, Tioga Medical was founded to provide physicians and patients with an elegant...
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) has announced that the US FDA has granted breakthrough yherapy designation for PB2452—a novel reversal agent for the antiplatelet drug ticagrelor. Breakthrough therapy designation is designed to expedite the development and review of promising...
An analysis on the impact of stroke severity in patients receiving the HeartWare HVAD system (Medtronic) as destination therapy shows that targeted blood pressure management helped reduce serious strokes. The HVAD system is a left ventricular assist device (LVAD)...
FEops has received CE mark approval for its FEops HEARTguide. According to a press release, FEops HEARTguide is a one-in-its-kind procedure planning environment for structural heart interventions that provides physicians with unique insights to evaluate device sizing and positioning...
Percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) remains one of the most demanding challenges for an interventional cardiologist. Technological developments have improved efficacy and safety, but complications still occur and their incidence remains higher than that observed...
Last year, the first two randomised controlled trials (RCT) looking at percutaneous edge-to-edge repair (MitraClip, Abbott) for the management of functional mitral regurgitation (MR) were published. MITRA-FR was presented at the 2018 European Society of Cardiology (ESC) Congress (25-29...
A pilot study, published as a research letter in the Annals of Internal Medicine, has found that patients who received comics or “medical graphic narratives”, as well as standard informed consent protocols (official consent form and a conversation with...
Between 2000 and 2014, in the USA, the percentage of patients with acute myocardial infarction cardiogenic shock (AMI-CS) who developed multiple organ failure increased from 15.7% to 45.5%. Furthermore, while use of angiography and percutaneous coronary intervention (PCI) in...
One-month dual antiplatelet therapy (DAPT) followed by 12 months of clopidogrel monotherapy leads to a greater reduction in bleeding events following percutaneous coronary intervention (PCI) compared to 12-month dual antiplatelet therapy, without an increase in ischaemia. Hirotoshi Watanabe (Kyoto...
Six-month "on-medication" results from the RADIANCE-HTN SOLO clinical trial have found that patients treated with the Paradise ultrasound denervation system (ReCor Medical Inc.) were prescribed fewer antihypertensive medications than those treated with a sham procedure, and accounting for this...
The European Commission (EC) has approved the use of alirocumab (Praluent, Sanofi), a PCSK9 inhibitor, in adults with established atherosclerotic cardiovascular disease (ASCVD) to lower low-density lipoprotein cholesterol (LDL-C) levels, reducing cardiovascular risk. Approximately seven million people have cardiovascular disease...
Richard Kovacs has become the new president of the American College of Cardiology (ACC). He officially assumed his role during the convocation ceremony held in conjunction with the ACC’s 68th Annual Scientific Session in New Orleans (16–18 March), and...
Evidence for the use of transcatheter aortic valve replacement (TAVI) as standard therapy is mounting, with the release of data from two major new studies that demonstrate its role in low-risk patients. Both were presented at late breaking trial...
Toby Rogers (Washington,DC, USA) tells Cardiovascular News that preliminary feasibility data from 12 patients reveals that use of a dedicated closure device for the aorta after transcaval TAVR has “eliminated” transcaval-related bleeding. Transcaval-related bleeding remains a lingering concern that...

Robert W Yeh

Robert W Yeh (Department of Medicine, Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA) believes that it is a “humbling privilege” that patients put so...
A subanalysis from the SURTAVI trial has found that transcatheter aortic valve implantation (TAVI) with Evolut R in intermediate-risk patients has lower rates of all-cause mortality or disabling stroke than surgical valve replacement 12 months after implantation. Steven J...
The AngelMed Guardian implantable device is as safe as using a pacemaker, with comparably low complication rates, and fewer delays in care than reliance on symptoms alone. It also has a higher positive predictive value and lower false positive...
The US FDA has approved a new indication for percutaneous edge-to-edge repair (MitraClip, Abbott), allowing its use for the reduction of moderate-to-severe or severe secondary mitral regurgitation in patients who are already receiving optimal medical therapy. When first approved...
Micro Interventional Devices chairman, president and CEO, Michael Whitman, and Oscor president and CEO Thomas Osypka, are pleased to announce a strategic alliance that leverages each company’s unique strengths and capabilities to further develop and commercialize innovative solutions to...
Admedus has received the CE mark for its CardioCel 3D product portfolio and its next-generation collagen bioscaffold VascuCel in Europe. According to a press release, this regulatory approval is an important step forward as the company continues to increase...
Beginning in mid-2019, hospitals performing transcatheter valve repair and replacement will be able to apply for the American College of Cardiology’s (ACC) new Transcatheter Valve Certification. The certification was announced at the ACC Quality Summit in New Orleans. A press...
 Carlo Di Mario (Florence, Italy) tells Cardiovascular News at CRT 2019 that there is “incredible” new data emerging that uses the transfemoral approach in low-risk TAVR patients. He also points out that severe arterial calcification in the iliac arteries...
 The renal denervation bubble collapsed due to a single trial—SYMPLICITY HTN-3, but this trial’s findings went against the grain, Horst Sievert (Frankfurt, Germany) tells Cardiovascular News at CRT 2019. Sievert shares early results of alcohol-mediated renal denervation, which were presented as a late-breaking...
 David Kandzari (Atlanta, USA) tells Cardiovascular News at CRT 2019 that renal denervation is typically showing magnitudes of blood pressure reduction that are clinically meaningful (approximately 10mmHg reduction in systolic and 5mmHg diastolic). While, these values are theoretically achievable...
Boston Scientific announced it has received CE mark and initiated a limited market release of the next generation Watchman FLX left atrial appendage closure (LAAC) device in Europe. Patients with AF are five times more likely to suffer a...
The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the post. Gottlieb announced his intention to stand down in a letter to Alex Azar II, the...
The Peregrine system infusion catheter (Ablative Solutions) has demonstrated 100% procedural success in the Peregrine post-market clinical trial, new data presented during a late-breaking session at the 2019 Cardiovascular Research Technologies (CRT) meeting (2–5 March, Washington, DC, USA) attests. The...

Northwestern Medicine Bluhm Cardiovascular Institute is pioneering the use of artificial intelligence (AI) for cardiac screening in a new study of Eko’s cardiac monitoring platform. The study aims to demonstrate that Eko’s digital stethoscopes and AI algorithms can interpret...
A press release reports that preliminary data from the BIOSOLVE-IV registry strengthen the clinical evidence in favour a bioresorbable magnesium scaffold (Magmaris, Biotronik) for de novo coronary artery lesions. Presented as late-breaking clinical data at the 2019 Cardiovascular Research...
Innovative Cardiovascular Solutions (ICS) has announced the first clinical use of its next-generation Emblok embolic protection system in patients undergoing transcatheter aortic valve implantation (TAVI) procedures in its European feasibility study. The cases were successfully performed by primary investigator...
According to a large observational study presented at Acute Cardiovascular Care 2019 (2–4 March, Malaga, Spain), myocardial infarction patients taken directly to heart centres for lifesaving treatment have better long-term survival than those transferred from another hospital. Directly admitted...
Three-year outcome data from the BIO-RESORT randomised controlled trial, which were presented at the 2019 Cardiovascular Research Technologies (CRT) meeting (2–5 March, Washington, DC, USA), confirmed the trend of earlier data supporting the use of the ultrathin biodegradable polymer...
Abbott has announced the US FDA clearance of the resting full-cycle ratio (RFR) diagnostic test to identify significant narrowing of arteries in patients with coronary artery disease. According to a press release, physicians can use Abbott’s RFR diagnostic test...
The Charing Cross International Symposium (CX) continues its three-year cycle of raising vascular and endovascular controversies in order to challenge the available evidence and be able to reach a consensus after discussion with an expert audience. CX will, as always,...
 Gary Ansel (Columbus, USA) tells Vascular News at VEITHSymposium 2018 about how drug-based therapies have become a mainstay in femoropopliteal revascularisation and how interventionalists should be using best medical therapy “more than we do ”. He also shares his...
A pooled data analysis comparing the Cre8 amphilimus-eluting stent (Alvimedica) and the BioFreedom biolimus-eluting stent (Biosensors) demonstrates similar safety and efficacy for the devices, with possible differences in treatment effect for patients with diabetes mellitus. Describing a combined investigation...
The Sapien 3 device (Edwards Lifesciences) can be safely and effectively used in transcatheter aortic valve implantation (TAVI) via the transcarotid approach in patients for whom the transfemoral route is not suitable, according to 30-day results from a multicentre...
MedAlliance has been granted breakthrough device designation from the US FDA for Selution—a sustained limus release drug-coated balloon catheter for the treatment of coronary disease. The FDA breakthrough device programme is intended to help patients receive more timely access...
Biotronik, the University of Newcastle (in Australia), and the John Hunter New England Local Health District have partnered to shape a future heart failure care model. A press release reports that investments by the Australian government and Biotronik have...
The American College of Cardiology will expand the Journal of American College of Cardiology (JACC) group of journals with the launch of JACC: CardioOncology in September this. Bonnie Ky (Perelman School of Medicine at the University of Pennsylvania, Philadelphia,...
At the MWC (25–26 February, Barcelona, Spain), formerly the Mobile World Congress, Philips unveiled a unique mixed reality concept developed in partnership with Microsoft for the operating room of the future. Based on Philips’ Azurion image-guided therapy platform and Microsoft’s...
Medtronic has received US FDA approval of its Resolute drug-eluting stent platform—including the Resolute Onyx and Resolute Integrity—for the treatment of patients with coronary artery disease who have de novo chronic total occlusion. Chronic total occlusions are considered to...
Robocath has obtained CE certification for its R-One robotic device. As a result, it can begin commercialisation in Europe and the Middle East. A press release reports that R-One is the first European robotic solution to obtain the CE...
  The US FDA have approved Biotronik’s drug-eluting stent Orsiro. A press release states that Orsiro is the first and only ultrathin drug-eluting stent to outperform the clinical standard (Xience, Abbott). The device received CE marking in 2011 and has...
This content is only for readers outside of the US as it discusses a device that is not FDA approved. Until recently, the tricuspid valve had the reputation for being the “forgotten valve”. According to Jörg Hausleiter (Medizinische Klinik und...
Recent years have seen many advances in education for cardiologists, but little attention has been paid to the impact of new technologies, particularly digital platforms and social networking. Digital education is evolving so rapidly that most patients, clinicians, and...
Mechanical circulatory support is frequently used to stabilise patient haemodynamics in desperate situations of circulatory failure to increase and maintain end organ perfusion.1 Of the available devices, the percutaneous micro-axial Impella (Abiomed) additionally provides a unique mechanism of left...
After receiving the CE mark for the device, iVascular launched its Navitian coronary microcatheter on to the market. A press release reports that the microcatheter can be used to facilitate, guide and support a guidewire while accessing the coronary...
Edwards Lifesciences now has the CE mark for its PASCAL transcatheter mitral valve repair system. According to a press release, the system is designed for reduction of mitral regurgitation while respecting the native anatomy. It features contoured, broad paddles to...
The American College of Cardiology (ACC) has launched a new initiative that leverages prospective clinical registry data and partnerships—spanning the pharmaceutical and medical device industry, health plans, employers, clinicians and patients—that aims to reduce the administrative burden associated with...
Philips Zenition, a new mobile C-arm imaging platform from Philips, has launched in the USA, Germany, Austria and Switzerland. It is being introduced into these countries over the next six months, and is set to penetrate other markets in...
 At the EKOS symposium at LINC 2019, Nils Kucher (Zurich, Switzerland), Houman Jalaie (Aachen, Germany) and Mert Dumantepe (Istanbul, Turkey) share their experiences in treatment of pulmonary embolism, acute and chronic deep venous thrombosis (DVT) using acoustic pulse thrombolysis. This...
A programme designed to help myocardial infarction patients with the transition from hospital to outpatient care can reduce readmissions and deaths and increase the number of patients keeping follow-up appointments, a new study suggests. The study—from the Sanger Heart...
A review, published in the Journal of the American College of Cardiology, of the financial hardship associated with atherosclerotic cardiovascular disease (such as coronary heart disease, myocardial infarction, angina, and stroke) indicates that one in five patients are unable...
Daniel J Blackman (Department of Cardiology, Leeds Teaching Hospital NHS Trust, Leeds, UK) and others report in the Journal of the American College of Cardiology (JACC) that in their study, 91% of patients remained free of severe structural valve...
At a press conference held at the National Research Center for Cardiac Surgery in Astana (Kazakhstan), heart failure experts from around the world announced the successful implantation of the fully Implanted ventricular assist device (FIVAD) into a human. Prior...
The Duke Children’s Pediatric & Congenital Heart Center (Duke University Medical Center, Durham, USA) treats the entire spectrum of patients with complex congenital heart disease. In this article, Cardiovascular News focuses on how the centre manages patients with congenital...
  In this commentary for Cardiovascular News, Stefan Toggweiler writes about how the Tricento device could address the current need in the management of tricuspid regurgitation and more. Tricuspid regurgitation is a common valvular heart disease that has been directly related...
The Lewisham and Greenwich NHS Trust (London, UK) has become the first NHS Trust in England (UK) to offer video consultations for cardiology patients—enabling them to have specialist advice they need without the hassle of travelling to hospital. However,...
A new survey by HeartFlow of more than 1,500 adults across the USA shows only 29% of respondents know that heart disease is the number one cause of death. The remaining 71% believe that health threats such as cancer,...
Our latest issue covers the top stories from TCT 2018, including COAPT, ULTIMATE, and FAST-FFR. We also profile Robert Yeh, interview David Kandzari about the latest data for Orsiro, and have a commentary on the resurgence of renal denervation.  
Our latest issue covers the top stories from TCT 2018, including COAPT, ULTIMATE, and FAST-FFR. We also profile Robert Yeh, interview David Kandzari about the latest data for Orsiro, and have a commentary on the resurgence of renal denervation.  
Teleflex has received premarket approval (PMA) from the US FDA for the Manta vascular closure device. A press release reports that the device is the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial...
Vectorious Medical Technologies has announced the initiation of the VECTOR-HF first-in-human (FIH) clinical trial, and the successful first “in-human” implantation of the V-LAPTM monitoring device. A press release reports that the trial will enrol up to 30 patients six...
The PrecludeSync Distal (Merit Medical) is now available in the US, European, Middle Eastern, African, and Asia-Pacific markets. The device is the first product specifically designed to achieve haemostasis of the radial artery during procedures where access is gained...
Alvimedica has announced the company has received the CE mark for the Cre8 Evo 2mm, a polymer-free Amphilimus-eluting stent. In a press release, Alvimedica states it is now able to offer more extensive treatment coverage for all those patients with complex...
Preliminary data from the BIOSOLIVE-IV registry are consistent with the favourable safety outcomes seen with the magnesium bioresorbable scaffold (Magmaris, Biotronik) in previous studies (BIOSOLVE-II and BIOSOLVE-III). Investigators Stefan Verheye (Cardiovascular Center ZNA Middelheim, Antwerp, Belgium) and others say...
CAUTION: The ACURATE neo aortic valve system is CE marked. In the USA, it is an investigational device—limited by US law to investigational use only; not available for sale. The ACURATE neo2 aortic valve system is an investigational device only;...
Abiomed has achieved the CE mark for Impella Connect, which—a press release reports—is the first-of-its kind cloud-based technology that enables secure, real-time, remote viewing of the Impella console for physicians and hospital staff from anywhere with internet connectivity. The...
Neovasc has announced that the Institut für das Entgeltsystem im Krankenhaus (InEk)— the German Institute for the Hospital Remuneration System—has awarded its Neovasc Reducer, a CE-marked medical device for the treatment of refractory angina, NUB status 1 designation again...
The editors-in-chief of major cardiovascular journals—of both US and European societies—have come together to “sound the alarm” about the dangers of medical misinformation that has been disseminated through the internet, social media, and other platforms. They claim that this...
The British Heart Foundation (BHF) has announced that it is now accepting proposals for its Big Beat Challenge—a single funding award of £30 million. The goal of the Challenge, according to a press release, is to push teams of researchers...
Experts from the Society for Cardiovascular Angiography and Interventions (SCAI) have reviewed the recent meta-analysis by Katsanos and colleagues and have concluded that the methods are appropriate and within constraints of trial-level meta-analysis. However, the society statement says “it...
CorMatrix Cardiovascular has received US FDA approval of an early feasibility study investigational device exemption (IDE) to evaluate the safety and feasibility of the Cor Tricuspid ECM cardiac valve for adults with endocarditis and for paediatric patients with congenital...
Martin T Rothman has been appointed as chief medical officer of Vascular Dynamics, effective 1 January 2019. Rothman is a pioneer in interventional cardiology, as evidenced by his clinical practice spanning several decades, his extensive pre-clinical and clinical research presented...
Martin T Rothman has been appointed as chief medical officer of Vascular Dynamics, effective 1 January 2019. Rothman is a pioneer in interventional cardiology, as evidenced by his clinical practice spanning several decades, his extensive pre-clinical and clinical research presented...
Philips launches its Azurion with FlexArm to aid patient imaging and positioning during image-guided procedures. During increasingly complex interventions, clinicians need to quickly and easily visualise critical anatomy and identify changes to the patient during the procedure. Azurion with FlexArm...
Three newly published studies highlight the safety, efficacy, and economic advantage of the Pervecal sutureless aortic valve (LivaNova). The results from the Perceval Aortic Heart Valve Study in North America, performed under a US FDA Investigational Device Exemption (IDE),...
It was recently announced that Abbott has exercised its option to purchase Cephea Valve Technologies. Financial terms were not disclosed. Abbott provided capital and secured an option to purchase Cephea in 2015. Cephea's technology is being developed to provide an...
The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new medical product applications. FDA commissioner Scott Gottlieb took to Twitter to highlight agency employees who are...
Data from the e-MUST study show that the absence of known cardiovascular risk factors is an independent risk factor for sudden cardiac arrest prior to hospital admission for ST-segment elevation myocardial infarction (STEMI). Other independent risk factors include younger...
New data indicate that patients who develop bundle branch block (BBB) and/or require a new permanent pacemaker after undergoing transcatheter aortic valve implantation (TAVI) have a significantly increased risk of late all-cause mortality. They also have a higher risk...
HeartFlow has announced the publication of the PACIFIC substudy showing that their FFRct Analysis demonstrates the highest diagnostic performance for detecting coronary artery disease (CAD) compared to other non-invasive tests. The HeartFlow Analysis is a non-invasive, personalised cardiac test that...
Medical device executive John T Kilcoyne has been appointed as chief executive officer of JenaValve Technology, effective immediately. In addition, he will serve as a member of the board of directors. Kilcoyne is a proven leader in the medical device...
  Shockwave Medical has initiated its US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study—DISRUPT CAD III—for the use of Intravascular Lithotripsy (IVL) in heavily calcified coronary arteries. IVL is an innovative lesion preparation tool designed to fracture...
  The first patients in the United Arab Emirates (UAE) have been treated with the Diamondback 360 Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems). The first UAE patients were treated by Aref Nooryani, chief executive officer and head of the Al Qassimi...
People who sleep less than six hours a night may be at increased risk of cardiovascular disease compared with those who sleep between seven and eight hours, suggests a new study published in the Journal of the American College...
The US Food and Drug Administration (FDA) has approved the Amplatzer Piccolo Occluder (Abbott), the world's first medical device that can be implanted in babies weighing as little as two pounds using a minimally invasive procedure to treat patent...
Boston Scientific and Edwards Lifesciences today announced that the companies have reached an agreement to settle all outstanding patent disputes between the companies in all venues around the world. All pending cases or appeals in courts and patent offices between...
Medicaid reimbursement to healthcare facilities on ST-elevation myocardial management—or STEMI, a serious form of a heart attack—is often lower when compared with the reimbursement rate of private insurance, according to a study published in the journal Circulation: Cardiovascular Quality...
The Society of Cardiovascular Computed Tomography (SCCT) has released a new expert consensus document for computed tomography imaging to improve outcomes for patients undergoing transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR). The 2019 guideline, a result of a...
December marked a significant milestone for a major study into the use of short duration dual anti-platelet therapy (DAPT) in high bleeding risk patients following stenting procedures, with patient recruitment reaching the half-way point. The ambitious investigator-initiated MASTER DAPT (Management...
The first US patient has been successfully treated with JC Medical's transfemoral transcatheter aortic valve implantation (TAVI) device, the J-Valve TF system. The patient was treated at The Christ Hospital (Cincinnati, USA) by Dean Kereiakes, medical co-director of the...
Ryan D Madder (Frederik Meijer Heart and Vascular Institute, Spectrum Health, Grand Rapids, USA) and others write in Circulation: Cardiovascular Interventions that increased body mass index (BMI) among patients undergoing cardiac catheterisation is associated with a significant increase in...
A meta-analysis of individual patient-level data from FAME 2, DANAMI-PRIMULTI and Compare-Acute indicates that percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) is associated with a significant reduction in a composite of cardiac death and myocardial infarction...
Ablative Solutions has announced the first close of its US$77 million Series D funding round. The round was led by new investor Glide Healthcare, and co-led by exiting investor BioStar Ventures, as well as an undisclosed new strategic corporate...
It has been announced that the Sapien 3 Ultra system (Edwards Lifesciences) has received US FDA approval for transcatheter aortic valve implantation (TAVI) in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk...
Joseph Lamelas, an internationally recognised expert cardiac surgeon who helped pioneer minimally invasive approaches to cardiac surgery, has joined the University of Miami Health System as chief of cardiothoracic surgery and professor of surgery within the Miller School of...
US FDA 510(k) clearance has been granted for the FFRangio System (CathWorks). The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish...
Boston Scientific has exercised its option to acquire the remaining shares of Millipede, upon its recent successful completion of a first-in-human clinical study. The acquisition will expand the Boston Scientific Structural Heart portfolio to include the IRIS Transcatheter Annuloplasty...
The first patients in the United States have been treated using the OrbusNeich Teleport Microcatheter (Teleport; Cardiovascular Systems), which recently received US Food and Drug Administration (FDA) 510(k) clearance. Microcatheters are used to provide support and safe guidewire exchange during...
Writing in Circulation: Cardiovascular Quality and Outcomes, David Ouyang (Stanford University, Falk Research Center, Palo Alto, USA) and others report that while the number of female first and senior authors of cardiovascular research papers has increased over the past...
A post-hoc analysis of FREEDOM (Future revascularisation evaluation in patients with diabetes mellitus: optimal management of multivessel disease) indicates that coronary artery bypass grafting (CABG) provides better outcomes—in terms of major adverse cardiac and cerebrovascular events (MACCE)—for diabetic patients...
BioCardia has announced its 510(k) submission for US FDA clearance of the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. A...
Merit Medical has announced the release of the Prelude IDeal hydrophilic sheath Introducer in European, Middle Eastern and African Markets. A press releases reports that the Prelude IDeal is designed primarily for use in radial access procedure and has...
A jury in the US District Court for the District of Delaware determined that the Boston Scientific US patent 8,992,608 is valid and that Sapien 3 transcatheter aortic valve implantation (TAVI) device infringes this patent and that Edwards owes...
A press release reports that Abiomed is to invest US$15 million in Shockwave Medical and the two companies will collaborate on a training and education programme in the USA and Germany focused on the benefits of complementary use of...
Edwards Lifesciences is to work with Bay Labs on improving the detection of heart disease. The partnership involves multiple initiatives, including the development of new AI-powered algorithms in Bay Labs’ EchoMD measurement and interpretation software suite, the integration of...
Matthias Meyer (Triemli Hospital, Zurich, Switzerland) and others report in European Heart Journal: Acute Cardiovascular Care women who are experiencing symptoms of a myocardial infarction (heart attack) wait for longer to call for assistance than men do. According to...
CorPath technology has been successfully used in the first-in-human telerobotic intervention study in India; the study is assessing the efficacy and safety of conducting percutaneous coronary intervention (PCI) from a remote location outside of the catheterisation lab. Five patients...
HeartFlow has announced the start of the PRECISE (Prospective randomised trial of the optimal evaluation of cardiac symptoms and revascularisation trial). The first patient was enrolled by Michael C Turner, (Imperial Health Cardiovascular Specialists, Lake Charles, USA). The PRECISE trial...
In draft recommendations, England’s National Institute for Health and Care Excellence (NICE) gives the go-ahead for percutaneous edge-to-edge repair (MitraClip, Abbott) for mitral regurgitation patients who are unable to undergo heart surgery because of a high risk of complications....
 “The real question is: who should get percutaneous coronary intervention (PCI)? I do not believe that we are doing too many PCIs but in some cases, we are not doing PCI in the right patient,” says Gregg Stone (New...
New data, just published in the Journal of the American Heart Association (JAHA), suggest that there is an increased risk of death at two and five years following the use of paclitaxel-coated balloons and stents in the femoropopliteal artery....
By Thomas Zeller The Katsanos et al meta-analysis reports an increased risk of mortality beyond one year across randomised studies of paclitaxel-coated balloons (DCB) and paclitaxel-eluting stents (DES). These observations are of great interest to the vascular specialist community. Even...
Sixty years ago, the first pacemaker implant was made in Stockholm, Sweden (Senning & Elmqvist) on 8 October 1958. The patient had atrioventricular block with recurrent Adams-Stokes attacks. These were prevented by the implant—although, it only functioned for a...
Reva Medical announced the first implant of its recently launched Fantom Encore bioresorbable scaffold in Italy. The implant procedure was performed by Antonio Colombo at the Columbus Clinic Center in Milan, Italy. A press release reports that Fantom Encore...
The first implant of the Pascal mitral valve repair device (Edwards Lifesciences) in the CLASP IID pivotal trial has been performed at the Atlantic Health System’s Morristown Medical Center (Morrison, USA). The CLASP IID trial—with Linda Gillam (Morristown Medical...
Transcatheter aortic valve implantation (TAVI) is now a well-established treatment for aortic stenosis and is approved as an alternative to surgical aortic valve replacement in high-risk and intermediate-risk patients. Increasingly, the transcatheter heart valves are also being used for...
JenaValve has received US FDA approval of expansion of its investigational device exemption (IDE) feasibility studies for the JenaValve pericardial transcatheter aortic valve implantation (TAVI) system with the Everdur system and Coronatix transfemoral delivery catheter. The approval expands eligible...
Ulf Näslund (Umeå University, Umeå, Sweden) and others report in The Lancet that sharing pictorial representations of personalised scans that show the extent of atherosclerosis to patients and their doctors results in a decreased risk of cardiovascular disease one...
Quidel has received the CE mark for its TriageTrue high sensitivity troponin I test for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in...
WeHealth by Servier, Servier Group’s e-health Business unit, and MobioSense, a leading semiconductor biosensor platform developer based in Taiwan and Boston, announced the closing of a partnership agreement to develop and commercialise a digital portable, High Sensitivity Troponin I...
The American College of Cardiology New York Cardiovascular Symposium will be held 7–9 December midtown Manhattan (New York, USA) to provide clinicians with in-depth reviews of the latest science and cutting-edge advances in cardiology, while offering guidance on effectively...
Quentin Fischer (Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada) and others report in Circulation: Cardiovascular Interventions that patients with pre-existing left bundle branch block (LBBB) have a significantly increased risk of requiring permanent...
At the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA), David Kandzari (Piedmont Heart Institute, Atlanta, USA) presented the two-year results of the BIOFLOW V study. These indicate that Orsiro (Biotronik) was associated with a significantly...
Insufficient blood flow towards the coronary vasculature following transcatheter aortic valve implantation (TAVI) is a dreadful complication. This can result in a wide spectrum of clinical manifestations ranging from simple angina months after TAVI to full circulatory collapse immediately...
The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about 20% of current 510(k) devices are approved on trials that compare novel devices to predicate...
More than ever before, arterial hypertension represents one of the greatest health threats and challenges for both patients and treating physicians. With the new adjustment and narrowing of blood pressures targets for antihypertensive treatment, the number of patients with...
The study of stem cells in regenerative medicine is a growing field of basic and clinical research, generating a broad interest and debate in the scientific and the public communities. The ability to mobilise and activate endogenous stem/progenitor cells...
 Artificial intelligence (AI) is already better than humans at reading specific radiographic findings. It will impact phycisians’ jobs, but because it can currently only do very specific things, it is not yet “that robot chasing you down a dark...
The results of the meta-analysis pooling all existing randomised controlled trials comparing Ti-no coated bio-active stents (such as Optimax, Hexacath) and drug-eluting stents were presented at the 2018 American Heart Association (AHA) scientific sessions (10–12 November, Chicago, USA) by...
According to the results of PADN-5, pulmonary artery denervation (PADN) is associated with significant improvements in haemodynamic and clinical outcomes in patients with post-capillary pulmonary hypertension (CpcPH). Shao-Liang Chen, who presented the results of the study at the 2018...
John A Dodson (New York University School of Medicine, New York, USA) and others report in JACC: Cardiovascular Interventions that patients over age 65 who are frail had a 50% higher risk of major bleeding when hospitalised during a...
The CE mark has been granted to the Sapien 3 Ultra (Edwards Lifesciences) transcatheter aortic valve implantation (TAVI) device, but a dispute between Edwards Lifesciences and Boston Scientific over a patent means that—for the moment—the device will not be...
Bay Labs and Northwestern Medicine have announced that the first patient has been enrolled in a first-of-its-kind study. The study will evaluate the use of Bay Labs’ EchoGPS cardiac ultrasound guidance software to enable certified medical assistants as medical...
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the recommendation by the Central Social Insurance Medical Council (Chuikyo) to provide reimbursement for HeartFlow FFRct Analysis. The HeartFlow Analysis has already received regulatory approval from the Japanese...
Ron Waksman The Lipid Rich Plaque (LRP) study indicates that cardiac patients with a high lipid core plaque burden index (LBCI), identified with near infrared spectroscopy (NIRS, Infraredx), are at increased risk of a major adverse cardiac event...
Data from the EARLY randomised trial indicate that patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) who undergo a very early invasive strategy (<2 hours) is associated with a significant reduction in recurrent ischaemic events compared with patients who...
A pilot study comparing a strategy of left ventricular unloading with the Impella CP device (Abiomed) and delayed reperfusion (up to 30 minutes after left ventricular unloading) with a strategy of left ventricular unloading and immediate reperfusion for the...

AHA 2018: REGROUP trial

In this video from the European Society of Cardiology, Roxana Mehran (Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York) discusses the results of the REGROUP study that was presented...
The FDA have given Medtronic approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system in patients with hypertension who are already prescribed anti-hypertension medications. A press release states that the SPYRAL HTN-ON MED trial...
Vivasure Medical has announced the European launch of the PerQseal closure device for large-bore transcatheter procedures, including transcatheter aortic valve implantation (TAVI), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR)—all of which require large bore femoral...
NeoChord has announced that it has completed a US$25 million Series D equity financing. Proceeds from the financing will be used to accelerate the development of the company’s transcatheter chordal repair and edge to edge programmes. The Series D...
An international study, led by researchers from the Intermountain Medical Center Heart Institute in Salt Lake City, found that a smartphone app (AliveCor) to monitor heart activity and determine if someone is having an ST-segment elevation myocardial infarction (STEMI) has...
The first patient in Hong Kong has been treated with the Diamondback 360 coronary Orbital Atherectomy System (Cardiovascular Systems). A press release reports that this procedure marks the first international coronary procedure taking place as a result of the...
BioCardia has announced that Mark Schwartz—a 25-year veteran of cardiovascular device development—has joined the company as Vice President of Clinical Affairs. A press release reports that Schwartz brings extensive leadership experience in the design and execution of clinical studies...
REDUCE-FMR indicates that indirect annuloplasty with the Carillon device (Cardiac Dimensions) is associated with a significant reduction in mitral regurgitation in patients with secondary mitral regurgitation. The trial was unique in that it was sham controlled and, therefore, suggests...
Cordis, a Cardinal Health company, has launched its Mynx Control vascular closure device onto the US market. A press release reports that the Mynx Control vascular control device integrates active extra vascular sealing and resorbability properties with a next-generation...
Reva Medical announced the commercial launch of the Fantom Encore bioresorbable scaffold and the first implant of the device in the FANTOM Post Market trial. Matthias Lutz (Universitätsklinikum Schleswig-Holstein, Kiel, Germany) performed the implant procedure. According to a press...
4TECH has initiated its US early feasibility study, following receipt of approval from the US FDA, with the successful first two implantations of the TriCinch Coil system at Piedmont Heart Hospital, Atlanta, Georgia, by Christopher Meduri, Vivek Rajagopal and...
A new study indicates that low air temperature, low atmospheric air pressure, high-wind velocity, and shorter sunshine duration are associated with an increased risk of myocardial infarction, with the strongest association being with air temperature. These findings help to...
A new meta-analysis of patients undergoing percutaneous closure of patent foramen ovale (PFO) after cryptogenic shock supports previous studies that indicate PFO closure is associated with an increased risk of atrial fibrillation. However, it also shows that device-related atrial...
According to a press release, Raimondo Ascione, Saadeh Suleiman (Bristol Heart Institute, University of Bristol, Bristol, UK) and colleagues are to develop and test a new drug combination that could protect the hearts of patients undergoing cardiac surgery. They...
CellProThera and BioCardia announced an agreement to expand their current collaboration to the SIngXpand clinical trial in Singapore. The study will evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand...
Data from the TriValve Registry—an international multicentre, retrospective, multidevice, registry evaluating interventional tricuspid repair—indicates that interventional edge-to-edge repair (MitraClip, Abbott) to manage patients with tricuspid regurgitation is associated with a high rate of procedural success, durable tricuspid regurgitation reduction...
The largest study to date of prosthesis-patient mismatch following transcatheter aortic valve implantation (TAVI) shows that severe mismatch is associated with a significantly higher risk of death at one year. Furthermore, the study indicates that the predictors of prosthesis-patient...
The collaboration agreement between iVascular and NaviGate Cardiac Structures (NCSI) has been formalised, meaning iVascular has acquired 10% of shares of NCSI for US$10 million dollars. With this purchase, a press release reports, iVascular becomes part of the Board...
The HeartMate 3 left ventricular assist device has received US FDA approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for...
At Asia Pacific MedTech Forum 2018 (9-10 October, Singapore), Cambridge Consultants demonstrated its single-use, high-definition miniature camera. Called “Leap”, according to a press release, the technology allows a digital view inside veins and arteries for the first time. The...
Micro Interventional Devices announced the world's first percutaneous implantation of its MIA, minimally invasive annuloplasty, technology for tricuspid and mitral repair.  This marks the first patient enrolled in the transcatheter arm of the STTAR (Study of transcatheter tricuspid annular...
Caristo Diagnostics, an Oxford University spinout company, has been launched to commercialise a new coronary CT image analysis technology that can identify patients at risk of fatal myocardial infarction years before they occur. Caristo’s technology, which has been developed...
Rivaroxaban, brand name Xarelto (Janssen), has received approval by the US Food and Drug Administration (FDA) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction and stroke, in people with chronic coronary or...
A new study indicates that transcatheter mitral valve implantation (TMVI) with the Tiara valve (Neovasc) can be safely and successfully implanted in patients with pre-existing aortic valve replacement. It also shows that the procedure can be performed without causing...
Tushar Acharya (National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, USA) and others report in JAMA Cardiology that within 10 years, the risk of all-cause mortality among patients who have had an unrecognised myocardial infarction is...
Transseptal Solutions has received FDA 510(k) clearance for its TSP Crosser transseptal access system. A press release reports that the system has a novel approach of transseptal puncture and left atrial navigation to introduce various cardiovascular catheters into the...
Teleflex has acquired Essential Medical, which has developed and commercialised the CE marked Manta vascular closure device—specifically designed for closure of large bore arteriotomies following procedures using devices or sheaths ranging in size from 10Fr to 18Fr (with maximum...
This content is only for readers outside of the USA First real-world case experience with the Cardioband Tricuspid System by Marcel Weber, Jan-Malte Sinning, Nikos Werner and Georg Nickenig. A 78-year-old female presented with dyspnea (NYHA III) and elevated NT-pro BNP...
Edwards Lifesciences has commenced the US pivotal trial that will study its self-expanding Centera transcatheter aortic valve implantation (TAVI) device for severe, symptomatic aortic stenosis patients at intermediate risk of open-heart surgery. The prospective, single-arm, multicentre study is expected...
Research presented at the 29th Great Wall International Congress of Cardiology (GW-ICC) meeting (11–14 October, Beijing, China) shows that just one-third of patients in China with acute coronary syndromes, including myocardial infarction, receive cardiac rehabilitation guidance before discharge from...
Jun-jie Zhang (Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China) and others report in the Journal of American College of Cardiology that percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS) is associated with a significantly...
UK-based charity Heart Research UK has given a Novel and Emerging Technologies (NET) Grant of £250,00 to Jack Lee (King’s College London, London, UK) and colleagues to further develop a test that uses artificial intelligence (AI) to identify patterns...
The revised European Society of Cardiology (ESC) myocardial revascularisation guidelines have downgraded the use of embolic protection devices during saphenous vein graft intervention from Class I (should be used) to Class IIa (reasonable to use).1 The change in recommendation...
This content is only for readers outside of the US as it discusses a device that is not FDA approved. Results from the SAVI-TF Registry1, which was recently published in JACC: Cardiovascular Interventions, show that the ACURATE neo (Boston Scientific)...

Olaf Wendler

Olaf Wendler (lead for Cardiothoracic Surgery, King’s Health Partners, and chair of the Heart and Vascular Institute of the Cleveland Clinic London, UK) performed the first transcatheter aortic valve implantation (TAVI) procedure in the UK. He is a course...
Venus Medtech has signed an agreement to acquire Keystone Heart, a privately-held medical device company and makers of TriGUARD 3—a cerebral embolic protection device that is designed to provide complete coverage to all brain regions for patients undergoing cardiac...
The Society for Cardiovascular Angiography and Interventions (SCAI) has announced that Megha Prasad has been selected as the recipient of the SCAI-Women in Innovations (WIN) CHIP Fellowship. The $100,000 fellowship opportunity was made possible with a grant from Abiomed...
Two-year data from the BIOFLOW-V randomised trial—which compared a sirolimus stent with a biodegradable polymer (Orsiro, Biotronik) with a everoliums-eluting stent with a permanent polymer (Xience, Abbott)—show improved outcomes for patients treated with Orsiro across a range of clinical...
According to one-year results from the PORTICO I study, which were presented during a late-breaking session at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA) and simultaneously published in the Journal of the American College...
New data presented at 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA), according to a press release, patients implanted with the CoreValve transcatheter aortic valve implantation (TAVI) system (Medtronic) experienced excellent valve durability out to five...
A new analysis of data from the Impella (Abiomed) Quality (IQ) Database shows a relative increase of 24% in mean survival in acute myocardial infarction cardiogenic shock patients since Impella’s cardiogenic shock FDA post-market approval. Part of the reason...
The primary endpoint results of the LEADERS FREE II trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA). They confirm that the favourable results gained earlier for the BioFreedom stent in the...
Data presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA) indicates that the performance of Restore (Cardionovum) matches that of latest-generation zotarolimus-eluting stent (Resolute, Medtronic) in patients with coronary small vessel disease. The data...
The FAST-FFR trial, which was presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA) and published in Circulation, indicate that fractional flow reserve (FFR) derived from an angiogram (FFRangio, CathWorks) had high sensitivity, specificity,...
Delegates at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21-25 September, San Diego, USA) broke into spontaneous applause after Gregg Stone (Columbia University Medical Center, Cardiovascular Research Foundation, New York, USA) reported that, according to the results of the...
Data presented yesterday at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21-25 September, San Diego, USA) indicate that there were no significant differences in the rate of target vessel failure between all-comer patients who underwent percutaneous coronary intervention (PCI)...
In our latest issue, we report on the top stories from the 2018 ESC Congress—including MITRAL.FR, CULPRIT-SHOCK (one-year data), and Low Risk TAVR. We also profile Olaf Wendler (London, UK), who talks about the potential impact of Brexit on...
In our latest issue, we report on the top stories from the 2018 ESC Congress—including MITRAL.FR, CULPRIT-SHOCK (one-year data), and Low Risk TAVR. We also profile Olaf Wendler (London, UK), who talks about the potential impact of Brexit on...
The US FDA has approved an investigational device exemption (IDE) to initiate a single-arm study to evaluate the CoreValve Evolut transcatheter aortic valve implantation (TAVI) system (Medtronic) in patients with bicuspid aortic valves who are at low risk of...
Cardiac Dimensions has announced the company has randomised its first patient in the CARILLON pivotal trial, which is evaluating the Carillon mitral contour system for the treatment of functional mitral regurgitation associated with heart failure as compared to a...
Speaking at PCR London Valves (9–11 September, London, UK) Didier Tchétché (Clinique Pasteur, Toulouse, France) reported that the one-year results of the VIVA (valve-in-valve) trial support previous 30-day findings that transcatheter valve-in-valve procedures with the CoreValve/CoreValve Evolut R device...
Data from the multicentre FAST-TAVI trial indicate that early discharge—discharge within 72 hours—in an all-comers population undergoing transcatheter aortic valve implantation (TAVI) is safe and feasible. Furthermore, these data show that prespecified criteria can help to identify patients who...
A new study evaluating the safety and performance of the Acurate neo2 (Boston Scientific) transcatheter aortic valve implantation (TAVI) system demonstrated a high procedural success rate and a low rate of paravalvular aortic regurgitation at 30-day post procedure. Results from...
Medtronic has announced the start of the Onyx ONE Clear Study in the USA and Japan that will evaluate one-month dual antiplatelet therapy (DAPT) in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary...
The US FDA has approved the PK Papyrus covered coronary stent system (Biotronik) under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations. A press release reports that the PK Papyrus is the first FDA...
Two patients have been successfully treated with Millipede’s latest-generation delivery system that incorporates a fully integrated intracardiac echocardiography (ICE) catheter. The catheter was designed to enhance the precise delivery and accurate placement of the company’s IRIS annuloplasty ring implant. A...
Results from the highly anticipated LRP (Lipid-Rich Plaque) study will be presented during a late-breaking clinical trial session at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA). The LRP Study a prospective, multicentre study is designed...
Corindus Vascular Robotics is to feature its CorPath GRX system at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA). The system is the first FDA-cleared medical device for robotic-assisted vascular interventions. A press release reports...
The Society for Cardiovascular Angiography and Interventions (SCAI) has announced the death of Joseph D Babb, who was president of SCAI from 2001 to 2002 and practised medicine at East Carolina Heart Institute at East Carolina University Brody School...

BTG buys Novate Medical

BTG has announced it has acquired Novate Medical (“Novate”), a medical device company focused on the prevention of pulmonary embolism in patients at high risk of venous thromboembolic events. A press release reports that Novate has developed Sentry; the...
Gore has acquired Pipeline Medical Technologies—a privately held medical technology company focused on advancing chordal repair for degenerative mitral regurgitation via a transcatheter procedure. The Pipeline repair device is designed to replicate the outcomes of a highly effective surgical...
Vascular Dynamics has revealed that enrolment of the first patients in an FDA-approved and best-in-class pivotal clinical trial has started. The CALM-2 study is designed to establish safety and efficacy of the novel endovascular baroreceptor amplification (EVBA) procedure using...
New results from the TMVR (Transcatheter mitral valve replacement) Registry show that patients with a degenerated bioprosthesis who undergo transcatheter mitral valve implantation (TMVI) have relatively low rates of all-cause mortality (14%) at one year. However, suboptimal procedural outcomes...
SIS Medical is to launch three new models of its balloon catheters—EasyT, NIC 1.1 hydro and NIC Nano hydro—and say all three have characteristics that define new standards for these types of catheters. The company has recently obtained approval...
Hiroto Yabushita and colleagues report in Circulation: Cardiovascular Interventions that drug-coated balloon treatment of in-stent restenosis lesions with three or more metallic layers results in a higher incidence of major adverse cardiovascular events and target lesion revascularisation than for...
Bjarne L Nørgaard (Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark) and colleagues report in the Journal of the American College of Cardiology (JACC) that the use of computer-derived fractional flow reserve (FFRCT, HeartFlow Analysis, HeartFlow) in patients with...
Amit N Vora (Duke University Medical Center/the Duke Clinical Research Institute, Durham, USA) and others report in in JACC: Cardiovascular Interventions that patients who develop atrial fibrillation after undergoing transcatheter aortic valve implantation (TAVI) have a higher risk of...
The LRT (Low Risk TAVR) trial did not find any significant differences in the rate of all-cause mortality between low-risk patients undergoing transcatheter aortic valve implantation (TAVI) and a historical control group of low-risk patients undergoing surgical aortic valve...
Milind Desai (Cleveland Clinic, Cleveland, USA) and colleagues have identified a novel imaging biomarker that has been found to be able to predict all-cause and cardiac mortality by measuring inflammation of fatty tissue surrounding the coronary arteries. Desai et al...
One-year follow-up data from the REDUCE LAP-HF I clinical study of the Interatrial Shunt Device (IASD, Corvia Medical) demonstrate shunt patency (blood flow from the left to right atrium) for all participants who received the implant. The IASD is...
One-year data from the CULPRIT-SHOCK trial indicate that there is no significant difference in all-cause mortality between cardiogenic shock patients undergoing immediate multivessel percutaneous coronary intervention (PCI) and those undergoing culprit-only PCI. These findings suggest that multivessel PCI is...
The GLOBAL LEADERS trial, simultaneously published in the Lancet and presented at the 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany), shows that a regimen of ticagrelor and aspirin for one month after percutaneous coronary intervention...
The 12-months results of the BASKET-SMALL 2 study, which were presented at the 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany), indicate that use of a drug-coated balloon (SeQuent Please, B Braun) to treat de novo...
According to the five-year results of the BIOSCIENCE trial, sirolimus-eluting stents with a biodegradable polymer (Orsiro, Biotronik) have a similar overall safety and efficacy profile as everolimus-eluting stents (Xience, Abbott). However, the study also found that all-cause mortality was...
This content is only for readers outside of the USA In an environment with growing demand for specialist cardiology services, it is important that health tech innovators support physicians to manage demanding workloads and complex procedures while ensuring the patient...
The first randomised controlled trial to compare percutaneous edge-to-edge repair (MitraClip, Abbott) with medical therapy alone in patients with secondary mitral regurgitation (to heart failure) has shown no evidence that the percutaneous device provides benefit in terms of prognosis....
Recently the Centers for Medicare and Medicaid Services (CMS) reopened the National Coverage Determination (NCD) for transcatheter aortic valve implantation (TAVI). Much of the discussion has focused on the TAVI and surgical valve volume requirements to start and maintain...
The final results of the FUTURE (Functional testing underlying revascularisation) trial indicate that more patients with multivessel disease and a high SYNTAX score (>32) undergo percutaneous coronary intervention (PCI)—as opposed to coronary artery bypass grafting (CABG)—when treatment is guided...
Thomas S Gilhofer (University Heart Center, Department of Cardiology, University Hospital Zurich, Zurich, Switzerland) and others report in Structural Heart that a combined procedure involving both transcatheter aortic valve implantation (TAVI) and left atrial appendage closure is a feasible...
A new study has found that the dual antiplatelet therapy (DAPT) score, which is recommended by both US and European guidelines, did not adequately determine ischaemic and bleeding risk in an unselected patient population. These findings suggest that the...
Data from the Canadian Spontaneous Coronary Artery Disease (CanSCAD) study indicate that the majority of patients with non-atherosclerotic spontaneous coronary artery dissection are young to middle-aged women who present with myocardial infarction. Furthermore, they indicate that, despite conservative therapy,...
At the 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany), British Heart Foundation (BHF) announced the “Big Beat Challenge”—an £30m award that seeks to bring together world-leading researchers and innovators to identify and solve any of...
Cerner has collaborated with Duke Clinical Research Institute to develop the atherosclerotic cardiovascular disease (ASCVD) Risk Calculator app, which is designed as a tool to increase communication between a patient and their doctor about ways to live a healthier...
At the 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany), Siemens Healthineers launched Magnetom Sola Cardiovascular Edition—a 1.5 Tesla magnetic resonance imaging (MRI) scanner that is specifically designed for cardiovascular examinations. A press release reports that...
WeHealth, by Servier, has launched Cardioskin—a connected solution that is designed to function as an ambulatory wearable 15-lead ECG—at the 2018 European Society of Cardiology Congress (25–29 August, Munich, Germany). A press release reports that Cardioskin is composed of...
Xarelto, co-administered with aspirin, is indicated in the EU for the prevention of atherothrombotic events in adult patients with coronary artery disease at high risk of ischaemic events. The European Commission (EC) has approved a combination of Xarelto (rivaroxaban) 2.5mg...
RenalGuard Solutions has announced the treatment of 20,000 patients with RenalGuard for the prevention of contrast-induced nephropathy. A press release reports that the system, which is currently used in Europe and other countries that recognise the CE mark, is...
More than 100,000 people have been trained in hands-only cardiopulmonary resuscitation (CPR) since the American Heart Association (AHA) launched its hands-only CPR training kiosk programme in 2016. As part of the programme, that is supported by Anthem Foundation in...

Juan F Granada

Juan F Granada (president and CEO, Cardiovascular Research Foundation, New York, USA) wanted to be a physician from a young age and fell in love with interventional cardiology when he saw balloon angioplasty performed. He talks to Cardiovascular News about...
ClearFlow has been awarded a group purchasing agreement—chest drainage contract: Contract # PP-OR-1561—for the chest drainage products category with Premier. A press release reports that the PleuraFlow ACT System is indicated for use following cardiothoracic surgical procedures and chest...
Philips has introduced the EPIQ CVx cardiovascular ultrasound system. Built on the EPIQ ultrasound platform, EPIQ CVx is specifically designed to increase diagnostic confidence and simplify workflow for clinicians—giving them more time to interact with their patients and reducing...
In this edition (Issue 50), we report on the key studies from EuroPCR 2018—SPYRAl HTN-ON, ORBITA FFR/iFR analysis, and FAME (five-year results). We also profile Juan F Granada (CEO of the Cardiovascular Research Foundation) and have a commentary on...
In this edition (Issue 50), we report on the key studies from EuroPCR 2018—SPYRAl HTN-ON, ORBITA FFR/iFR analysis, and FAME (five-year results). We also profile Juan F Granada (CEO of the Cardiovascular Research Foundation) and have a commentary on...
This content is only for readers outside of the US as it discusses a device that is not FDA approved. The granting of the CE mark to Edwards Lifesciences for its Cardioband Tricuspid System was an important development for patients...
In a new position paper, published in the European Heart Journal, the Sports Cardiology Section of the European Association of Preventive Cardiology (EAPC) outline recommendations for coronary artery disease patients participating in sport (both for leisure and for competitive...
A feasibility study of a novel left atrial appendage device (Ultraseal, Cardia) indicates that the device is associated with a high rate of procedural success and a fast learning curve. It also suggests that the device has an extremely...
Rafael A Meneguz-Moreno (Department of Interventional Cardiology, Instituto Dante Pazzanese De Cardiologia, Sao Paulo, Brazil) and others report on JACC: Cardiovascular Interventions that after very long-term follow-up, 75% (i.e three quarters) of patients exhibit sustain results after undergoing percutaneous...
Data from OPTIMIST (Options in myocardial ischemic syndrome therapy) registry indicate that a quarter (25%) of patients with refractory angina who are initially deemed to be “no option” for revascularisation will go on to have such an intervention. Furthermore,...
The US FDA has sent a letter to transplant surgeons and cardiologists about the Syncardia temporary Total Artificial Heart (TAH-t) Companion 2 Driver. The letter states the final results of the post-approval study of the system indicate that it...
CathWorks has announced that its FAST-FFR trial is fully enrolled ahead of schedule. The trial is designed to evaluate efficacy of the CathWorks FFRangio system in terms of sensitivity and specificity when compared to conventional invasive fractional flow Reserve...
The first study to compare the use of transcatheter aortic valve implantation (TAVI) with conservative management in patients with chronic kidney disease (3–5) indicates that mortality is significantly higher with conservative management. This suggests that although patients with chronic...
A new study, published in JAMA Network Open, indicates that patients with atrial flutter have a lower incidence of stroke than patients with atrial fibrillation who have the same CHA2DS2-VASc score. Given current European guidelines advise that patients with...
Chun Shing Kwok (Keele Cardiovascular Research Group, Keele University, Stroke-on-Trent, UK) and others report in JACC: Cardiovascular Interventions that only 0.5% of percutaneous coronary intervention (PCI) patients discharge themselves against medical advice (DAMA). However, they note that the risk...
A new study published in Mayo Clinical Proceedings indicates that the rate of acute myocardial infarction among pregnant women increased between 2002–2003 and 2012–2013 (7.1 per 100,000 hospitalisations vs. 9.5% per 100,000 hospitalisations; p<0.01 for trend) and this coincides...
Brad N Greenwood (Carlson School of Management, University of Minnesota-Twin Cities, Minneapolis, USA) and others report in Proceedings of the National Academy Sciences of the United States of America that female patients with acute myocardial infarction who are treated...
At present, a bicuspid aortic valve is seen as a relative contradiction for transcatheter aortic valve implantation (TAVI) and, thus, surgical aortic valve replacement is the preferred approach in most of these patients. However, surgery is not always possible...