Boston Scientific (NYSE:BSX) and Edwards Lifesciences (NYSE:EW) said today that they’re burying the hatchet, settling their worldwide patent war over cardiac valve and implant technology, with Edwards paying $180 million to end the dispute. “All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate […]
Cardiac Implants
Abbott wins FDA approval for Amplatzer Piccolo occluder for neonates
The FDA granted pre-market approval for the Amplatzer Piccolo occluder made by Abbott (NYSE:ABT) to treat a congenital heart defect in neonatal infants as small as two pounds, the company said today. The Chicago-area healthcare giant said Amplatzer Piccolo is a transcatheter, self-expanding, wire mesh device that’s inserted via the aortic or pulmonary artery to close a […]
Thubrikar Aortic Valve launches Brazilian TAVR trial
Privately held medical device developer Thubrikar Aortic Valve said yesterday that it launched a Brazilian trial of its Optimum transcatheter aortic valve using the company’s implantation system. The Norristown, Penn.-based company touted that the first human implant has been performed in the trial, which is being sponsored by the company’s Brazilian licensee, Labcor Laboratórios, who […]
FDA gives Edwards’ Sapien 3 Ultra TAVR the nod
Edwards Lifesciences (NYSE:EW) can now market its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in the United States. The FDA approved the device for severe, symptomatic aortic stenosis patients for whom open-heart surgery is considered an intermediate or greater risk, the Irvine, Calif.-based company said. For the Ultra, Edwards has added a taller […]
Meril Life Sciences wins approval for TAVR in India
Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report. 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 panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator
The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency […]
Pivotal trial kicks off for Edwards Lifesciences’ Pascal mitral repair device
A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said. The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with […]
BTG’s bioconvertible IVC filter implanted in Arizona patients
BTG (LSE: BTG) today announced the first successful implantation of its Sentry bioconvertible inferior vena cava (IVC) filter in patients outside of a clinical trial. The Sentry device won FDA 510(k) clearance in 2017. London-based BTG acquired the device in September through its purchase of Galway, Ireland–based Novate. Get the full story on our sister site Medical […]
Conformal Medical raises $9m Series B for anti-stroke cardiac implant
Conformal Medical said today that it raised $9 million in a Series B round for the anti-stroke cardiac implant it’s developing. Nashua, N.H.-based Conformal is working on a left atrial appendage seal to prevent stroke in atrial fibrillation patients. It’s designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging […]
Is the medical device industry endangering people?
The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny. The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about […]
Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival […]