Edwards Lifesciences (NYSE:EW) issued an urgent field safety notice this week warning customers that it received reports of difficulty tracking and manipulating its Centera TAVR system around the aortic arch. The company said that the issue has caused vascular injury including aortic dissection and death during early cases. The observed incidence of serious events related to […]
Cardiac Implants
CMS expands TAVR coverage
The Centers for Medicare and Medicaid Services have updated the criteria for hospitals and physicians to begin or continue providing transcatheter aortic valve replacement surgery. The decision gives hospitals and providers more flexibility to meet the CMS requirements for performing TAVR, the agency said Friday. The original National Coverage Determination (NCD) for TAVR procedures was cleared in […]
Meril Life Sciences’ MyVal TAVR wins CE Mark
Indian medtech maker Meril Life Sciences said it has won the CE Mark for its MyVal-THV system, a transcatheter aortic valve replacement (TAVR) developed exclusively in India. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells […]
FDA clears Gore’s Cardioform ASD occluder
W.L. Gore & Associates said today that it won FDA premarket approval for its Gore Cardioform ASD occluder designed for the percutaneous closure of ostium secundum atrial septal defects. Approval came supported by data from the pivotal stage of Flagstaff, Ariz.-based Gore’s ASSURED clinical study, which reported a 100% closure success rate at six months post-implant. […]
Biotronik launches next-gen ICD, CRT-D trial
Biotronik said yesterday that it launched a study of its new implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems. The BIO|MASTER.Cor Family study will explore clinical safety and workflow benefits of its ICD and CRT-D systems, specifically focused on gains from the thinner and more rounded shape, the Berlin-based company said. Biotrink said that […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. […]
Boston Scientific study to compare Watchman FLX with anticoagulant drugs
Boston Scientific (NYSE:BSX) said yesterday that it’s launching a large clinical trial to compare the latest iteration of its Watchman heart implant with anticoagulant drugs in reducing the risk of stroke in atrial fibrillation patients. The 1,600-patient Option randomized trial is designed to compare first-line oral anticoagulants with left atrial appendage occlusion using Watchman FLX in […]
HRS 2019: Study shows no danger to CRM devices from airport body scans
Airport body scanners don’t appear to interfere with pacemakers and defibrillators, and noninvasive neurostimulation through the ear may help treat AFib. Those are but some of the insights coming out of the Heart Rhythm Society’s annual scientific sessions, held this week in San Francisco. Here are some of the research highlights coming out of the […]
Medtronic wins FDA nod for quadripolar Attain Stability left heart lead
Medtronic (NYSE:MDT) said today it won FDA approval for its Attain Stability quad MRI SureScan left heart lead, touting it as the only active-fixation left heart lead on the market. The newly cleared Attain Stability left heart leads are meant to be paired with the Fridley, Minn.-based company’s quadripolar cardiac resynchronization therapy-defibrillators and pacemakers, and feature […]
Cardiac Dimensions touts data from Carillon TMVR device study
Cardiac Dimensions today released results from a trial of its Carillon mitral contour system intended for treating functional mitral regurgitation in patients with heart failure, touting significant reductions in regurgitant volume after implantation. Results from the trial were presented at the German Society of Cardiology annual congress, the Kirkland, Wash.-based company said. The percutaneous Carillon device […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]