The Latest Cardiac and Vascular News
MALVERN, Pennsylvania, Oct. 2, 2017 /PRNewswire/ — Essential Medical today announced the completion of enrollment in the US pivotal IDE trial of the MANTA large bore vascular closure device. “Our team is thrilled with the enthusiasm of investigators and sites that accelerated MANTA study enrollment,” commented Todd Sorzano, Director of Operations at Essential […]
The Federal court upheld a previous coronary stent win over Dr. David Jang Appeals court upholds Boston Scientific win over stent pioneer Jang BY BRAD PERRIELLO, MassDevice A federal appeals court today upheld a Boston Scientific (NYSE:BSX) win over coronary stent pioneer Dr. David Jang. The case dates back to 1999, when Jang won […]
Endovascular Graft Systems: Letter to Health Care Providers – Type III Endoleaks Associated with Use [Posted 09/28/2017] AUDIENCE: Risk Manager, Surgery, Cardiology, Radiology ISSUE: The FDA is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular […]
EDEN PRAIRIE, Minn., Sept. 28, 2017 (GLOBE NEWSWIRE) — CHF Solutions, Inc. (NASDAQ:CHFS) announced today that it is initiating international distribution of its products by entering into a distribution agreement with APC Cardiovascular Ltd., a distributor based in the United Kingdom. APC Cardiovascular will market CHF Solutions’ Aquadex FlexFlow® System and will serve as CHF Solutions authorized service provider […]
DUBLIN – September 27, 2017 – Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, […]
ANAHEIM, Calif.–(BUSINESS WIRE)–ClearFlow Inc., a medical device company based in Anaheim, California, has announced the publication of significantly positive results in a study evaluating the company’s PleuraFlow® Active Clearance Technology® System. Data from a peer-reviewed clinical study indicating a marked reduction in Postoperative Atrial Fibrillation (POAF) among patients with active clearance of chest […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova”) and MicroPort Scientific Corporation (HK:00853) (“MicroPort”), today announced that the companies’ Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management Co. Ltd. (“MSC” or the “joint venture”) obtained approval for its family of RegaTM pacemakers from the China Food and Drug Administration. Not only are Rega pacemakers […]
TEL-AVIV, Israel, September 28, 2017 /PRNewswire/ — Magenta Medical, a medical device company in the field of transcatheter heart failure therapy, announced today the successful closing of its $15M series B financing round. The syndicate of investors is comprised of Abiomed Inc., a leader in transcatheter heart pumps, Pitango Venture Capital, among Israel’s leading venture capital […]
As an agency dedicated to promoting public health, and as fellow Americans, the staff at the U.S. Food and Drug Administration is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. First and foremost, these efforts are focused around our mission […]
RESEARCH TRIANGLE PARK, NC and TORONTO, CANADA, September 27, 2017 — Analytics 4 Life, a digital health company applying the power of artificial intelligence to develop solutions that improve existing care pathways, today announced it has completed a $25 million Series B financing. This unique financing event was supported by an […]
