An FDA advisory panel voted unanimously in favor of approval for a drug-coated balloon to treat patients with peripheral artery disease (PAD). The first-of-its-kind device is indicated for use in the femoropopliteal arteries.

EKOS Corporation, a BTG International group company, today announces the start of patient enrollment for the ACCelerated ThrombolySiS for Post-Thrombotic Syndrome using the EKOS System (ACCESS PTS) Study.

Moving toward U.S. market introduction of its novel medical device to treat peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced that it recently submitted the final module of its pre-market approval (PMA) application for the IN.PACT Admiral drug-coated balloon to the U.S. Food and Drug Administration (FDA). The application includes data that demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularization) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.

Privately-held ReliantHeart, a leading innovator in mechanical circulatory support therapies, today announced the first advanced stage heart failure patient received its next generation HeartAssist5 Ventricular Assist Device (VAD) since the company earned CE Mark approval for design enhancements just weeks ago.  Cardiologists at the Deutsches Herzzentrum Berlin (DHZB - German Heart Institute) in Germany performed the life-saving procedure.

The FDA approved the CoreValve device for transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis without a review from an expert panel. While the favorable decision was expected, the road to it developed a few potholes.

Women diagnosed with peripheral artery disease (PAD) were more likely to experience complications during peripheral vascular interventions than male counterparts, a study published June 17 in the Journal of the American College of Cardiology found. Nonetheless, both sexes had similar rates of procedural success.

Use of home visits and multidisciplinary clinics helped to reduce all-cause readmissions and death up to six months after an index hospitalization for patients with heart failure, while telephone-based interventions also showed some success, according to a review of transitional care trials. But none seemed to lower 30-day readmission rates.

Hospitals that readily embraced transradial PCI over a three-year period were more likely to see reduced bleeding rates, an analysis of CathPCI data showed. But even facilities that had modest increases in radial PCI use achieved lower access site and overall bleeding rates.