The Latest Cardiac and Vascular News
Gottlieb updates on Puerto Rico med device manufacturing recovery OCTOBER 20, 2017 BY SARAH FAULKNER In the weeks following Hurricanes Irma and Maria, the people and leadership in Puerto Rico have been working to rebuild the island’s infrastructure. The FDA, which has been working with federal and local agencies, today provided an […]
EXTON, Pennsylvania, Oct. 9, 2017 /PRNewswire/ –Essential Medical, Inc. today announced initiation of enrollment in a post market clinical registry in the regions where MANTA is commercially available. Principle Investigator Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands stated, “MANTA has quickly become […]
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 […]
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, […]
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 […]
MARLBOROUGH, Mass., Sept. 27, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF). The Excalibur Balloon leverages the proven universal balloon design of the company’s FDA-approved HeartLight® Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed […]
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for […]
Approval of CE Mark paves the way for application expansion and the exploration of new therapeutic areas for ground-breaking surgical solutions. Paris, France, September 11, 2017 – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue reconstruction, announced today that it has received CE Mark approval […]
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 […]
by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) It has the makings of a plot for a blockbuster movie: a high ranking government official or world leader assassinated by a nefarious hacker who remotely accesses an implanted cardiac device. Plot lines and prominent world leaders notwithstanding, cyber-security risks for implantable cardiac […]
