The Latest Cardiac and Vascular News
Philips subsidiary Spectranetics recalls Bridge occlusion balloon AUGUST 31, 2017 BY BRAD PERRIELLO , MassDevice Royal Philips (NYSE:PHG) subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens. The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was […]
REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that Anthem Blue Cross Blue Shield, Blue Shield of California, and Blue Cross and Blue Shield of Alabama have each issued a positive medical policy for the HeartFlow® FFRct Analysis, a first-of-its-kind noninvasive technology that helps clinicians diagnose and treat patients with suspected coronary artery […]
LONDON, Aug. 31, 2017 /PRNewswire/ — Frost & Sullivan is pleased to recognize PQ Bypass with the 2017 European PAD Interventions Technology Innovation Award. PQ Bypass’ DETOUR System is a minimally invasive technology that enables physicians to re-direct, or detour, blood flow around extremely long blockages in the upper leg arteries to restore […]
by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) Balloon expandable stents have been the mainstay in treating blockages in the iliac arteries for years. However, recent data suggests a change is in order. According to researchers who recently compared the two versions in a large group of patients being treated in […]
ABBOTT PARK, Ill., Aug. 29, 2017 – Today, Abbott notified physicians of updates to its implantable pacemakers and defibrillators as part of its ongoing commitment to continuously improve patient care. The new device updates include a Battery Performance Alert for our implantable cardioverter defibrillators (ICDs) that provides physicians with earlier […]
ABBOTT PARK, Ill., Aug. 30, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced it has initiated a U.S. pivotal clinical study evaluating the safety and effectiveness of a modified version of its AMPLATZER™ device designed to correct a common congenital heart defect that occurs in approximately 80,000 i,ii pre-term infants in the U.S. each year. […]
Looks like the FDA will be increasing the user fees for fiscal 2018 Most FDA user fees set to rise 33% AUGUST 30, 2017 BY BRAD PERRIELLO, MassDevice The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising […]
Landmark Data Published by The Lancet Demonstrates Statistically Significant Lower Event Rates with Orsiro BARCELONA, Spain, August 28, 2017 – BIOTRONIK today announced data from the BIOFLOW-V randomized trial comparing Orsiro1 and Xience2 drug-eluting stents (DES) with 12-month target lesion failure (TLF) as the primary endpoint proving non-inferiority. Results presented at the […]
SILVER SPRING, Md.–(BUSINESS WIRE)–Aziyo Biologics, Inc. a fully integrated regenerative medicine company, today announced completion of patient enrollment in SECURE, a prospective post market study of 1,000 patients treated with CanGaroo® ECM® Envelope in conjunction with cardiac implantable electronic device (CIED) placement. The CanGaroo ECM Envelope is intended to securely hold a […]
DANVERS, Mass., Aug. 28, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has accepted the resignation of its Chief Financial Officer, Michael Tomsicek, effective August 24, 2017. After two years, Mr. Tomsicek is leaving the Company to pursue other […]
