The American Heart Association (AHA), in conjunction with the American Association for Respiratory Care (AARC) and American Society of Anesthesiologists (ASA) is offering guidance in oxygenation and ventilation management for healthcare providers as hospital volumes surge from COVID-19. AHA released...
The reduced levels of angiotensin converting enzyme (ACE) 2 associated with cardiovascular disease and increasing age lead to a higher susceptibility to greater disease severity in COVID-19. A viewpoint published online in JAMA Cardiology hypothesises that severe acute respiratory...
Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials of its transcatheter mitral and tricuspid therapies in response to ongoing COVID-19 pandemic. A press release reports that the company is coordinating closely with the trials’...
The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May this year. The postponement, a press...
Athena Poppas (Providence, USA) is the new president of the American College of Cardiology (ACC). Her term officially began at the close of the ACC/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual). Poppas has been a long-standing leader of...
Simon Ray, president of the British Cardiovascular Society (BCS), has told the COVID-19 Cardiovascular Conference that a lack of consistency in national guidance around personal protective equipment (PPE) during COVID-19 had led to a “vacuum” which has had to...
In a new statement published on 2 April 2020, all 45 societies represented by the US Council of Medical Specialty Societies (CMSS)—over 800,000 physicians—emphatically declare their belief that all frontline healthcare professionals must have access to personal protective equipment...
A raised troponin level in myocardial injury “greatly alters the prognosis adversely” in COVID-19 patients, Graham Cole (Imperial College Healthcare NHS Trust, London, UK) told a virtual cardiovascular conference, hosted today by Imperial College London. Cole explained: “Troponin rises occur...
The COVID-19 Cardiovascular Conference, hosted as a live webinar by The Imperial College Network of Excellence in Vascular Science at Imperial College (London, UK), has heard about experiences from both Italy and the USA, as well as details of...
Cardiologists from across Europe have shared their experience of having treated COVID-19 patients, in a series of videos produced by the European Society of Cardiology (ESC), part of a suite of resources provided by the society to aid physicians...
The American College of Surgeons (ACS) today leapt to the defense of healthcare workers who are heading to work in the face of increasing concerns over personal protective equipment (PPE) shortages as the COVID-19 pandemic cuts trails across the...
Daniel M Philbin Jr has been named chair of the American College of Cardiology (ACC) board of governors and secretary of the board of trustees, the main governing body of the ACC, for 2020–2021. His term began at the...
The Imperial College Network of Excellence in Vascular Science at Imperial College London (UK) is to run a COVID-19 Cardiovascular Conference as a live webinar on Thursday 2 April for all healthcare professionals battling COVID-19. The webinar aims to share...
According to Geu-Ru Hong (Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea), edoxaban may be an alternative to warfarin for preventing thromboembolism in the first three months after surgical bioprosthetic valve replacement or repair....
Results from the phase 2 MAVERICK-HCM clinical trial, presented at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual) suggest that the use of mavacamten (MyoKardia) for the treatment of non-obstructive hypertrophic cardiomyopathy (nHCM) may be...
The longest follow-up to date of patients with left main coronary artery disease (LMCAD) has found no significant differences in rates of death, myocardial infarction or stroke between patients who underwent percutaneous coronary intervention (PCI) and those who had...
Today at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual)—originally scheduled to take place on 28–30 March in Chicago, USA—D Scott Lim (University of Virginia, Charlottesville, USA) reported that mitral regurgitation ≤1+ was achieved more frequently with MitraClipNTR or with MitraClipXTR (both Abbott) than...
Using the radial artery instead of the saphenous vein for patients undergoing coronary artery bypass graft (CABG) surgery leads to lower mortality and better cardiac outcomes, according to research presented at the American College of Cardiology’s Virtual Scientific Session...
Medtronic today announced positive results of the Onyx ONE Clear Study that evaluated the Resolute Onyx drug-eluting stent (DES) in high bleeding risk (HBR) patients with one-month dual antiplatelet therapy (DAPT) in the USA and Japan. Results from the...
“More bleeding with background clopidogrel, even if not severe by adjudication, may be associated with broad consequences, including discontinuation of therapies. In the absence of clear benefit, clopidogrel exposure along with aspirin and rivaroxaban should be minimised or avoided...
Transcatheter aortic valve implantation (TAVI) procedures had a high rate of success and low risk of death or disabling stroke at 30 days in patients with a bicuspid aortic valve, according to research presented by Basel Ramlawi (Valley Health,...
Three months after undergoing renal denervation, patients with untreated high blood pressure had statistically significant reductions in average blood pressure over 24 hours compared with patients who underwent a sham procedure according to results from the SPYRAL-HTN OFF MED pivotal...
Data from the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry, which enrolled more than 38,000 patients implanted percutaneously with the Watchman device (Boston Scientific), reveal a high implant success rate and a low rate of...
In the POPULAR TAVI trial, patients with atrial fibrillation who took oral anticoagulants alone after undergoing transcatheter aortic valve replacement (TAVI)—had a lower rate of bleeding complications without an increased risk of clotting-related complications, compared to patients who took...
During the first Featured Clinical Research session of the virtual American College of Cardiology (ACC) event (28–30 March, Central Time), Michelle Samuel (Montreal Health Institute, Montreal, Canada) reported that the addition of low-dose colchicine (0.5mg daily) to standard-of-care therapy...
In stable atherosclerosis, a combination of aspirin plus rivaroxaban provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral endpoints in patients with and without diabetes, a prespecified analysis of the COMPASS trial has shown. It also...
Treatment with aspirin plus rivaroxaban following lower extremity revascularisation in patients with peripheral arterial disease (PAD) leads to a 15% reduction in the risk of major adverse limb and cardiovascular events when compared with aspirin alone. The VOYAGER PAD study...
Today, during the Virtual American College of Cardiology (ACC) event (28–30 March, Central Time), Naveen L Pereira (Mayo Clinic, Rochester, USA) told the online audience that using genetic testing to guide antiplatelet therapy after percutaneous coronary intervention (PCI) does...
During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of...
A viewpoint in the Journal of the American Medical Association (JAMA) has offered potential solutions to modifying ongoing randomised clinical trials during the COVID-19 pandemic. It aims to “minimise disruption and preserve integrity”, while still ensuring participant health and...
Cardiac injury is common among hospitalised patients with COVID-19, and is associated with a higher risk of in-hospital mortality, a study from Wuhan, China, has shown. Although the exact mechanism of cardiac injury has not been defined, the researchers...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its response to the COVID-19 public health emergency in its day-to-day operations with industry. The letter from...
The American Heart Association (AHA) has committed US$2.5 million to research efforts to better understand the novel coronavirus, COVID-19, and its interaction with the body’s cardiovascular and cerebrovascular systems. Specifically, the Association will be offering fast-tracked research grants for short-term...
The British Cardiovascular Intervention Society (BCIS) and the British Cardiovascular Society (BCS) have endorsed guidance published by NHS England and NHS Improvement on the provision of cardiology services during the COVID-19 pandemic. A joint statement from Nick Curzen, president of...
The Society for Cardiology and Angiography Interventions (SCAI) has set up a dedicated section on its website to keep interventional cardiologists up to date on practice and safety measures required for interventional practice in COVID-19. The society has also...
CroíValve has announced the successful first human use of its Duo Tricuspid Coaptation Valve technology for tricuspid repair. The company says the procedure was performed by an experienced heart team in St James’ University Hospital (Dublin, Ireland). A statement from...
A new Heart & Stroke guideline published today in the Canadian Medical Association Journal does not recommend taking ASA (Acetylsalicylic acid) as a preventive measure for those who do not have a history of stroke or heart or vascular disease,...
A case series of US experience with COVID-19 has upheld suggestions of a link with cardiomyopathy, which developed in 33% of intensive care patients. In a research letter published in the Journal of the American Medical Association, Matt Arentz (Department...
The US Food and Drug Administration (FDA) has issued an immediately-in-effect guidance that allows manufacturers of certain FDA-cleared non-invasive, vital-sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices...
The first report on the impact of COVID-19 on heart transplant recipients has been published in The Journal of Heart and Lung Transplantation, outlining the management strategy by a team in Wuhan for two patients who contracted the virus...
Frailty is an independent predictor of morbidity, death, and increased costs after mitral valve replacement (MVR), a retrospective cohort study has determined. Writing in The Annals of Thoracic Surgery, Amit Iyengar (Division of Cardiac Surgery, and Perelman School of Medicine,...
The Society for Cardiovascular Angiography and Interventions (SCAI) has written an open letter to members detailing options for managing patients in the cath lab who present with COVID-19. SCAI president Ehtisham Mahmud, (University of California, San Diego) points out: “A...
Data from a pilot imaging study of commissural alignment in trancatheter aortic valve implantation (TAVI) has found that more than 30–50% of cases had overlap with one or both coronary arteries. Gilbert HL Tang (Mount Sinai Medical Center, New...
European CE mark has been awarded to the TriGUARD 3 cerebral embolic protection (CEP) device from Keystone Heart, a Venus Medtech Company. According to the company, TriGUARD 3 is the only CE marked product designed to cover and protect all...
Portola Pharmaceuticals announced new data that they say reinforces the value of Andexxa (coagulation factor Xa , inactivated-zhzo]. The company statement outlines that the data demonstrate Andexxa was associated with a lower rate of in-hospital and 30-day mortality in...
Early improvement in health status for patients in the COAPT trial who had transcatheter mitral valve repair (TMVr) with the MitraClip (Abbott) was strongly associated with reduced long-term risk of death or heart failure hospitalisation. COAPT investigators Suzanne V Arnold...
Patients who have a percutaneous coronary intervention (PCI) for chronic total occlusion following a coronary artery bypass graft (CABG) have worse outcomes than those without prior surgery, a meta-analysis published in JACC: Cardiovascular Interventions has found. The research was...
The novel left atrial appendage (LAA) closure device Appligator (Append Medical) was a finalist in the 2019 ICI Innovation Award Competition (Innovation in Cardiovascular Interventions 2019; 8–10 December, Tel Aviv, Israel).  Leonid Sternik, who came up with the concept...
Abbott made history in January when it became the first company in the world to receive market approval for a transcatheter mitral valve implantation (TMVI) device. Its Tendyne system now has a CE-mark indication for the management of patients...
The American College of Cardiology Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) is to run as a virtual meeting, following its cancellation due to the coronavirus outbreak. It was scheduled to take place 28–30 March 2020 in...
Vascular remodelling may occur in response to sustained, regular exercise, suggests a study of aortic dilatation among long-term endurance athletes. Timothy W Churchill (Massachusetts General Hospital, Boston, USA) et al found a “marked increase in the prevalence of aortic...
Abbott has received CE mark in Europe for the new FlexNav delivery system for the company's Portico transcatheter aortic valve implantation (TAVI) system. A statement from the company says that with the approval, physicians implanting Portico can benefit from...
The New England Journal of Medicine (NEJM) has launched a review into the data from the EXCEL trial, two members of the BBC Newsnight team have reported in the BMJ. Deborah Cohen and Ed Brown from the Newsnight current...
A short film (“Today is a Good Day”), which showcases the work of Aortic Dissection Awareness UK & Ireland, has won the Rare Disease Film Festival’s Peoples’ Choice award. According to Rare Disease UK, the organisers of the event, the film festival...
NOTE: This video is ONLY available to watch in selected countries and geographies Rajesh Kharbanda (Oxford, UK) and Oliver Husser (Dortmund, Germany) talk to BLearning Cardio about some of the major advancements in TAVI procedures over the past few years as well...
NOBLE finds PCI inferior to CABG at five years in left main disease EXCEL: repeat revascularisation after both CABG and PCI leads to increased mortality Profile: Nicolas van Mieghem BIBA Briefings: Sapien 3 becomes first TAVI valve to...
NOBLE finds PCI inferior to CABG at five years in left main disease EXCEL: repeat revascularisation after both CABG and PCI leads to increased mortality Profile: Nicolas van Mieghem BIBA Briefings: Sapien 3 becomes first TAVI valve to...
Paclitaxel drug coated balloons (DCB) for percutaneous treatment of coronary artery disease (CAD) are not associated with increased mortality, and longer term evaluation suggests a trend towards lower mortality compared to control therapies. The authors of a meta-analysis of...
Findings from an interim analysis of PROTECT III have added to the evidence for improved outcomes with Impella heart pumps in protected percutaneous coronary intervention (PCI). PROTECT III is part of the PROTECT series of trials initiated by Abiomed...
CryoLife has received CE mark for the On-X Ascending Aortic Prosthesis (AAP), allowing resumed distribution in the European Union. The On-X AAP is indicated for the treatment of diseased, damaged or malfunctioning native or prosthetic heart valves in the aortic...
The US Food and Drug Administration (FDA) has cleared a new version of the LivaNova Heater-Cooler System 3T, which is used during cardiothoracic surgery to warm or cool a patient to improve medical care and patient outcomes. The changes—designed,...
Endotronix has announced the enrollment of the first two patients in the PROACTIVE-HF trial. The trial is a premarket investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella pulmonary artery pressure sensor system (Cordella sensor)...
A research project at the University of Leeds aiming to identify new drug treatments for heart failure patients has been awarded a grant of almost £150,000 by British charity Heart Research UK.  The project, which will be led by Scott...
Transcatheter aortic valve implantation (TAVI) is safe in the short term in low-risk patients with symptomatic, severe bicuspid aortic stenosis (AS). Researchers also noted that subclinical leaflet thrombosis was present in a minority of patients at 30 days, but...
Patients who develop stage 3 acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) have seven times higher adjusted one-year mortality than patients who do not develop AKI. Researchers also found that more than 10% of patients develop...
Biotronik has announced three-year data from the BIOFLOW-V trial, which were presented at the Cardiac Resynchronisation Therapy meeting (CRT 2020; 23–25 February, Washington DC, USA). A statement from the company says the three-year findings demonstrate consistently lower clinical event...
Append Medical, developer of the Appligator, a novel left atrial appendage (LAA) closure device to minimise stroke risk in atrial fibrillation (AF) patients, and Sheba Medical Center (Ramat Gan, Israel), have announced the clinical proof-of-concept data evaluating the safety...
Edwards Lifesciences has announced a new goal for its philanthropic initiative, Every Heartbeat Matters (EHM), which aims to improve the lives of 2.5 million additional underserved structural heart and critical care patients by the end of 2025. The company...
A comparison of newer generation self-expanding valves (SEV) and balloon-expandable valves (BEV) in high-risk patients with aortic stenosis undergoing transfemoral transcatheter aortic valve implantation (TAVI) has found that they are equivalent for the primary valve-related efficacy endpoint. The authors...
Ablative Solutions has revealed that positive six-month results from the Peregrine post-market study demonstrating the safety and efficacy of the company’s CE-marked Peregrine System infusion catheter were published in the Journal of the American College of Cardiology: Cardiovascular Interventions. The...
Cardiovalve has received US Food and Drug Administration (FDA) approval for an early feasibility study (EFS) of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation (TR) indication. The Cardiovalve System has also been granted Breakthrough Device Designation...
Last month, Abbott announced US Food and Drug Administration (FDA) approval of a new trial—REPAIR MR—to evaluate the safety and efficacy of percutaneous edge-to-edge repair (MitraClip) for the management of patients with primary mitral regurgitation at moderate surgical risk....
The news programme BBC Newsnight has made further claims that the EXCEL investigators “held back” data from the published results of the left main trial. In a programme that aired on 18 February, reporter Deborah Cohen claims that Gregg...
VitalConnect has announced the introduction of arrhythmia detection to its remote monitoring portfolio. In partnership with CorVitals, VitalConnect now offers physicians the ability to monitor, diagnose and treat patients suffering from various heart conditions and diseases. With arrhythmia detection, clinicians...
Gregg W Stone (Icahn School of Medicine, Mount Sinai, New York, USA) addressed the EXCEL controversy today at the Joint Interventional Meeting (JIM 2020; 13–15 February, Milan, Italy), stipulating that although percutaneous coronary intervention (PCI) has early advantages and...
Nicolas van Mieghem

Nicolas van Mieghem

Nicolas van Mieghem (professor of interventional cardiology, department of cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands) shares his thoughts on a wide range of topics with Cardiovascular News, including mechanical circulatory support and artificial intelligence, the durability...
The US Food and Drug Administration (FDA) has authorised marketing of software to assist in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance (Caption Health), is an accessory to compatible diagnostic ultrasound systems and...
Orsiro Mission DES

Orsiro Mission gets CE mark

Biotronik has received CE mark certification for the Orsiro Mission drug-eluting stent (DES) system. According to a company statement, the next generation of the ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents. Orsiro Mission is now...
Philips has announced a new randomised controlled trial to assess percutaneous coronary intervention (PCI) guided by its coregistration platform, which combines data of an instant wave-Free Ratio (iFR) measurement and an angiogram, compared with standard of care treatment guided...
Scott Lim (Charlottesville, USA) talks to BLearning Cardio at PCR London Valves 2019 (17–19 November, 2019; London, UK) about the challenges associated with transcatheter tricuspid valve intervention. Lim explains that the patient population with tricuspid regurgitation is very heterogeneous, and so there is a need for a...
 Philippe Pibarot (Québec, Canada) talks to BLearning Cardio at PCR London Valves 2019 (17–19 November, 2019; London, UK) about the main data findings in the PARTNER 2 trial which evaluated more than 2,000 intermediate-risk patients with severe aortic stenosis who either underwent a TAVI procedure...
BioVentrix has received renewal of the highest priority reimbursement in Germany for its Revivent TC transcatheter ventricular enhancement system. A company statement announced that it has been given NUB Status 1 designation from InEk, the German Institute for Hospital...
Extended 10-year follow-up has demonstrated that in patients with a high SYNTAX score undergoing left main coronary artery (LMCA) revascularisation there is a clear prognostic benefit for coronary artery bypass graft (CABG) over percutaneous coronary intervention (PCI). PCI was...
The debate over the results of EXCEL shows no sign of abating, and there seems to be a division between cardiac surgeons and interventional cardiologists about which side of the argument they fall on, with surgeons generally supporting EACTS,...
Medtronic has announced that it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radio frequency (RF) ablations....
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott for its in-development fully implantable left ventricular assist system (FILVAS). The FDA Breakthrough Device Designation programme will allow, according to Robert L Kormos (medical director...
Rajiv Patni has been appointed as executive vice president and chief medical officer at Portola Pharmaceuticals, effective immediately. The company announced the appointment in a press release, stating that Patni will report to Scott Garland, president and chief executive...
 Frank Arko (Charlotte, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA), about the benefits of using Shockwave Intravascular Lithotripsy (IVL) when performing EVAR and TEVAR through calcified iliac arteries. Arko, who shares some of the downsides of traditional procedures...
Guy’s and St Thomas’ and Royal Brompton & Harefield NHS Foundation Trusts are to merge. A joint statement from the two trusts has announced their plans for closer working, indicating that the arrangements include the creation of a hub...
The Tendyne transcatheter mitral valve implantation (TMVI) system (Abbott) has received the CE mark, making Abbott the first company to have such a device on a market anywhere in the world. A press release reports that this “life-changing” therapy...
Highly-tweeted articles are 11 times more likely to be cited than less tweeted articles, Ourania Preventza (Division of Cardiothoracic Surgery, Baylor College of Medicine, Houston, USA) told delegates at the 56th Annual Meeting of The Society of Thoracic Surgeons...
David Hayes, former physician administrator at Mayo Clinic, Rochester, USA, has been appointed chief medical officer of Biotronik, a company press release reports. "Our focus has always been on the patient. To help patients live their best lives, we remain...
Open heart surgery remains the best option for young and middle-aged adults with aortic valve disease, for now; However, the use of transcatheter aortic valve implantation (TAVI) is continuing to expand to a wider group of eligible patients, according...
Patients discharged three days after open heart surgery are not at increased risk of complications, an analysis of discharge patterns has shown. S Chris Malaisrie (Northwestern Medicine, Chicago, USA) unveiled the findings at the 56th Annual Meeting of the Society...
NOTE: This video is ONLY available to watch in selected countries and geographies Azeem Latib (New York, USA) talks to BLearning Cardio about some of the major advancements in TAVI over the past few years including the...
Terumo has announced the launch of a new randomised clinical trial: the DIStal vs. COnventional RADIAL access trial (DISCO RADIAL). The trial compares the novel distal radial access with conventional radial access approach, in terms of radial occlusion rates...
The largest study to date of the role of frailty indices after transcatheter aortic valve implantation (TAVI) has demonstrated that the markers of low albumin, anaemia, and slow walking speed are significant independent predictors of mortality and morbidity in...
The TASTE and TOTAL studies suggested that routine thombus aspiration in patients undergoing percutaneous coronary intervention (PCI) did not provide mortality benefit and may increase the risk of stroke. However, a new study (CHEETAH) is evaluating whether a next-generation...
FEops has announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial. The trial is led by Righshospitalet (Copenhagen, Denmark) and aims to assess whether the use of FEops HEARTguide computer simulations based on cardiac CTimaging can...
George Adams (Raleigh, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA) about the benefits of using easy-to-use Shockwave IVL (Intravascular Lithotripsy) in calcified below-the-knee vessels, which he says, results in “great outcomes”. Adams explains that calcific plaque, particularly medial...
Emboline has completed enrolment in its SAFEPASS 2 clinical study of the Emboliner embolic protection catheter. A press release from the company, which develops total embolic protection technology for transcatheter aortic valve implantation (TAVI), also indicates that early results...
BioCardia has received US Food and Drug Administration (FDA) 510(k) clearance for its Morph DNA deflectable guide catheter, used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart. A company statement explains that the...
Spartan Bioscience, a maker of precision medicine diagnostic solutions, has established a new scientific advisory board (SAB) in Europe for cardiac stent patients that consists of international clinical and academic interventional cardiologists. The company says the role of the...
A secondary analysis of repeat revascularisation in the EXCEL trial has found that it was associated with increased mortality after both percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in patients with left main coronary artery disease...
The Society of Thoracic Surgeons (STS) has issued a statement on the controversy surrounding EXCEL, commenting that “that the final interpretation regarding the outcomes of the EXCEL study should wait until an independent analysis of all aspects of the...
The American College of Cardiology (ACC) has announced several promotions and structural changes within its senior staff. The College said that the staff changes will “further consolidate and strengthen the organisation’s efforts in achieving its strategic goals, mission and...
Abbott has announced that the US Food and Drug Administration (FDA) has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott's MitraClip device to open heart mitral valve surgical repair in people with primary mitral regurgitation...
A retrospective registry comparing four self-expanding transcatheter heart valves has demonstrated good haemodynamic performance in small aortic annuli, with low post-procedure gradients, large orifice areas, and a low incidence of severe patient–prosthetic mismatch (PPM). Writing in JACC: Cardiovascular Interventions, investigators...
Abbott has announced US Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that the company says will allow more advanced heart failure patients to avoid open heart surgery. The...
B Braun has announced the appointment of Jean-Claude Dubacher as chairman and CEO. Dubacher joined B Braun on 1 August 2019 as president, B Braun Medical. A press release reports that Dubacher’s experience in the healthcare industry spans more...
Proximo Medical is to partner with CeloNova Biosciences, supplier of the COBRA PzF nanocoated coronary stent (NCS), in select US markets. Carl St Bernard, chief executive officer of CeloNova Biosciences, states in the press release: “By partnering with Proximo Medical,...
The European Association of Cardio-Thoracic Surgeons (EACTS) has issued a statement reaching out to EXCEL investigators to “offer assistance” in resolving concerns raised about data from the trial. In a letter sent to the principal investigators, EACTS recommends that...
The European Association of Cardio-Thoracic Surgeons (EACTS) has published a detailed account of the process that led to its “unprecedented” decision to reverse its endorsement of a section of its joint 2018 myocardial revascularisation guidelines, developed with the European...
Five-year data from the NOBLE trial have confirmed its earlier findings that in patients with unprotected left main coronary disease the risk of major adverse cardiac or cerebrovascular events (MACCE) is higher with percutaneous coronary intervention (PCI) than with...
The Society for Thoracic Surgeons (STS) and the European Association of Cardio-Thoracic Surgeons (EACTS) have announced that they will participate in a strategic collaboration. A joint press release issued by Robert SD Higgins, president of the STS, and Domenico Pagano,...
The US Food and Drug Administration has granted Breakthrough Device designation to the digital health and artificial intelligence (AI) company Eko for an echocardiogram (ECG)-based algorithm to help identify induced Left Ventricular Ejection Fraction (LVEF). FDA Breakthrough Device designation helps...
Daiichi Sankyo Europe has announced outcomes from an observational study in mainly caucasian atrial fibrillation (AF) patients being treated with the anti-coagulation drug edoxaban (Lixiana). The results of the Danish observational cohort study, published in the European Heart Journal...
A pivotal, multicentre clinical trial is exploring the use of an Impella heart pump (Abiomed) to unload the left ventricle for 30 minutes prior to coronary revascularisation. The aim of the trial is to test the hypothesis that unloading...
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. Both Edwards and Medtronic (with its CoreValve Evolut range) have FDA approval...
Gregg Stone (The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA), on behalf of the EXCEL leadership, has sent Cardiovascular News (and other media outlets) a 3,500-word document refuting the...
George Dangas (Mount Sinai Hospital, New York, USA) told delegates in a late-breaking trial session at the American Heart Association Scientific Sessions (AHA 2019; 16–18 November, Philadelphia, USA) that “in patients without an established indication for oral anticoagulation after...
  The European Association of Cardio-Thoracic Surgery (EACTS) has withdrawn its support of the left main recommendations of the society’s joint guidelines with the European Society of Cardiology (ESC) on myocardial revascularisation following an investigation into the EXCEL trial by the...
InnovHeart—a developer of novel transcatheter mitral valve replacement (TMVR) systems—has appointed medical device entrepreneur J Brent Ratz as nonexecutive independent member of its Board of Directors. A press release reports that Ratz has more than 19 years of experience...
Data from the CAP and CAP2 registries—which contain the longest and largest follow-up of patients—add to previous evidence that left atrial appendage closure (LAAC) with Watchman (Boston Scientific) is a safe and effective alternative to long-term anticoagulation in patients...
Bioventrix has announced online publication of positive one-year results from its CE mark study of the Revivent TC System in the European Journal of Heart Failure. The paper will be published in print in the January issue. A press statement...
The TASTE and TOTAL studies suggested that routine thombus aspiration in patients undergoing percutaneous coronary intervention (PCI) did not provide mortality benefit and may increase the risk of stroke. However, a new study (CHEETAH) is evaluating whether a next-generation...
  A significant milestone has been reached for a landmark study into the use of short duration dual anti-platelet therapy (DAPT) in high-bleeding-risk (HBR) patients following stenting procedures, with patient recruitment just completed. A total cohort of approximately 4,500 patients have...
Michael Reardon (Houston, USA) talks to BLearning Cardio about the ADAPT tissue technology (Admedus), and the increasing importance of durability as TAVI moves to younger and lower risk patients. Reardon notes that “we would like to have technology that does even better...
The largest trial to date to compare revascularisation with a conservative strategy in patients with stable ischaemic heart disease has found no additional benefit a median of three years after the procedure. Data from the ISCHEMIA trial were presented at...
Preprocedural administration of an oral colchicine load does not reduce the risk of myocardial injury or 30-day major adverse cardiovascular events (MACE) in patients undergoing percutaneous coronary intervention (PCI), according to findings from the COLCHICINE-PCI (Effects of acute colchicine...
Meril has announced positive data on its Myval Transcatheter Heart Valve System at PCR London Valves 2019 (17–19 November 2019). A follow-up of 100 patients with intermediate- to high-risk for surgical aortic valve replacement (SAVR) in the MyVal-1 study...
Corindus has announced the completion of the first multicity, transcontinental percutaneous coronary intervention (PCI) simulations in the USA over three network connection types: 5G wireless, dedicated fibre, and commercial public internet networks. A press release reports that Ryan Madder...
The Revivent transcatheter ventricular enhancement system (Bioventrix) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). The Revivent investigational transcatheter device uses micro-anchors to cinch together the scarred area of the left ventricle to...
An analysis of structural valve deterioration in the PARTNER 2A trial has found that the third generation Sapien 3 transcatheter heart valve (Edwards Lifesciences) has similar durability to surgical valves, with the second generation Sapien XT (also Edwards Lifesciences)...
The use of TriClip (Abbott) for edge-to-edge repair in tricuspid regurgitation (TR) remains safe and effective at one year, preliminary outcomes from the TRILUMINATE study, presented at a late-breaking session at PCR London Valves 2019 (17–19 November, London, UK),...
Permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is associated with increased mortality at six years, particularly in patients who are pacemaker dependent. At an abstract session at PCR London Valves 2019 (17–19 November, London, UK), Giuliano...
Endotronix has presented first-in-human data of the Cordella pulmonary artery pressure sensor System at the 2019 American Heart Association (AHA) Scientific Sessions (16–18 November, Philadelphia, USA). Data were presented by Wilfried Mullens (Hospital Oost-Limburg, Genk, Belgium). The 90-day results from...
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...

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...
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...