Two studies presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference directly compared Boston Scientific Corp.’s Watchman 2.5 and Watchman Flx to Abbott Laboratories’ Amplatzer Amulet device. Both showed Amulet had less than half as many leaks, but the clinical impact of the lower rate remained unclear.
Catheter-based delivery of replacement valves is established practice for patients with aortic regurgitation, but the mitral valve has only repair devices to address this condition. However, transcatheter mitral valve replacement (TMVR) devices by Dublin-based Medtronic plc., and triscupid valve replacement devices by Edwards Lifesciences Inc. of Irvine, Calif., made some noise at this year’s edition of Transcatheter Cardiovascular Therapeutics (TCT), suggesting that these patients might soon have a wider range of options.
The U.K. National Institute for Health and Care Excellence said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp. (BSX), are ready for prime time in the U.K. national health system.
It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?
A new study has found that despite the risk, many patients are open to interventional procedures such as renal denervation (RDN) if it can lead to improved blood pressure. RDN is performed under local anesthetic and uses radio frequency ablation to burn the nerves in the renal arteries. The process causes a reduction in nerve activity, which decreases blood pressure.
Despite the morbidity associated with coronary artery bypass graft, this procedure has never been entirely displaced by percutaneous coronary intervention. The results from the latest in a series of studies does not seem to help the case for drug-eluting stents (DES) for patients with three-vessel disease, as the data from this study failed to demonstrate non-inferiority for DES devices implanted with the help of fractional flow reserve measurement to ensure optimal stent placement.
The FDA convened a Nov. 2 advisory panel to review the data for the AFX2 by Endologix LLC, of Irvine, Calif., with some indication that the agency believes the data suggest a poor benefit-risk ratio when used in treatment of abdominal aortic aneurysms (AAAs). The panel concluded that the benefits of the device do outweigh the risks for some patients, although the applicable patient population is likely to be smaller than is currently seen in clinical practice.
Alivecor Inc. is partnering with blockchain technology company Solve.Care to connect users of its Kardiamobile device to physicians through a telehealth network. Tallinn, Estonia-based Solve.Care’s blockchain platform, the Global Telehealth Exchange (GTHE), is an open global cross-border telehealth network currently available in 27 countries. Alivecor’s Kardiamobile 6L device is the first and only six-lead personal ECG cleared by the FDA. Through the partnership, Kardiamobile devices will be integrated with GTHE where physicians will be able to access a user’s electrocardiogram (ECG) reading upon their consent through teleconsultations.
PARIS – Teams from the Pitié-Salpêtrière hospital, the Institute for Research in Development, Sorbonne University and the National Institute of Health and Medical Research are proposing a new technique that uses artificial intelligence (AI) to identify the risk of developing a type of cardiac arrhythmia called Torsades de pointes (TdP) associated with taking certain drugs.
Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows.
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