Other News

Celebrating The 20th Anniversary Of The W. L. Gore & Associates EXCLUDER Device

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) today announced the 20th anniversary of the first implant of the GORE® EXCLUDER® AAA Endoprosthesis, the most-studied** endovascular aneurysm repair (EVAR) device on the market, with more than 300,000 patients treated* worldwide. The GORE EXCLUDER Device provides physicians with a proven and durable option to […]

Essential Medical Completes Enrollment In US IDE Trial For The MANTA Large Bore Vascular Closure Device Used Primarily In Percutaneous Heart Valve Replacement Procedures

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 […]

FDA Warns Physicians on Endoleaks With Stent Grafts

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 […]

CHF Solutions Initiates International Distribution with UK-Based APC Cardiovascular Ltd.

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 […]

Medtronic HeartWare(TM) HVAD(TM) System Approved for Destination Therapy

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, […]

Newly Published Peer Reviewed Study Reveals Benefits Of ClearFlow’s PleuraFlow ACT System

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 […]

LivaNova (LIVN) And MicroPort Scientific (MCRPF) Announce The Approval Of Rega Pacemakers By The China Food And Drug Administration

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 […]

Abiomed (ABMD) Gets in on Magenta Medical’s $15 Million Funding Round

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 […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico

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 […]