Abbott’s (NYSE:ABT) MitraClip heart valve device may secure Medicare coverage for an additional procedure. The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation, which results from left ventricular dysfunction. Medicare already pays […]
Cardiac Implants
V-Wave wins breakthrough nod for heart failure device
V-Wave said today that the FDA has granted breakthrough device designation for its interatrial shunt for heart failure (HF). The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced […]
AtriCure offers $300m for SentreHeart
AtriCure (NSDQ:ATRC) said today that it put up a $300 million offer for SentreHeart and its Lariat left atrial appendage closure device. Redwood City, Calif.-based SentreHeart has enrolled 535 patients in the Amaze trial comparing Lariat and pulmonary vein isolation with PVI alone in treating atrial fibrillation. Today AtriCure said it expects the study tor each […]
FDA approves Endotronix trial for Cordella PA pressure sensor
Endotronix last week announced that it received FDA approval to begin its multi-center Proactive-HF trial of the Cordella Pulmonary Artery Pressure Sensor System. The trial is designed to help the Cordella Sensor reach pre-market approval faster and will begin enrollment in the third quarter of 2019. “We are excited to begin enrollment in this groundbreaking […]
Edwards Lifesciences abandons Centera self-expanding TAVR for Sapien 3 Ultra push
Edwards Lifesciences (NYSE:EW) is discontinuing work on its Centera TAVR system as it increases focus on expanding indications for its Sapien 3 Ultra valve. The news — which came yesterday with the company’s second-quarter earnings announcement — comes weeks after an urgent field safety notice in which the company warned customers that it had received reports […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
Abbott wins FDA approval for its fourth-generation MitraClip
Abbott (NYSE:ABT) announced today that U.S. FDA has approved the MitraClip G4, the most advanced version yet of the company’s transcatheter heart valve repair device to treat mitral regurgitation. Abbott expanded the number of clip sizes to four for the MitraClip G4, including clips with a wider grasping area, in order to expand the treatment options […]
Keystone Heart inks distribution agreement with Vasorum
Keystone Heart has started distributing Ireland-based Vasorum’s Celt ACD vascular closure device in the U.S. and Europe, effective this month. Approved by FDA in 2016, the Celt ACT is a biocompatible implant meant to close femoral artery punctures taking place after catheterization. Health providers have implanted the CeltACT in more than 40,000 patients to date. […]
Abbott recalls select Ellipse ICDs due to damaged wires
Abbott (NYSE:ABT) began voluntarily recalling 204 Ellipse implantable cardioverter defibrillators in June to prevent the use of devices that may have a vulnerability in the electronic circuitry due to damaged wires, according to a recently-filed urgent field safety notice. The company stressed that it has not received any product performance complaints or adverse patient events related […]
Procyrion raises $30m Series D for Aortix heart pump
Procyrion said this week that it closed a $30 million Series D round for its Aortix percutaneous blood pump. The Aortix blood pump is designed to treat patients with heart failure and worsening kidney function. The pump is thinner than a pencil and can be placed in less than 10 minutes during a cath-lab procedure. […]
Cardiologist questions use of Boston Scientific Watchman device
A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention. The Watchman left atrial appendage closure device is designed to prevent blood clots that form in the heart’s left atrial appendage from reaching the brain. Boston Scientific (NYSE:BSX) markets it as an alternative to blood-thinning […]