The Latest Cardiac and Vascular News
By Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) An aspirin a day has been a standard recommendation for those diagnosed with certain types of coronary disease for decades. However, knowing patients like we do, medication non-compliance is a real problem -especially when it comes to recommended non-prescription drugs. So, what happens […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a developer and innovator of crossing and support catheters for use in the treatment of occlusive cardiovascular disease, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Wingman14C Crossing Catheter for use in conjunction […]
IRVINE, Calif.–(BUSINESS WIRE)–TherOx, Inc., a privately held medical device company focused on improving treatment of Acute Myocardial Infarction (AMI), announced that the U.S. Food and Drug Administration (FDA) has accepted the Premarket Approval (PMA) application for its Supersaturated Oxygen (SSO2) Therapy system. The second-generation SSO2 Therapy system is designed to reduce […]
AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today the first commercial use of the HAART 200 Aortic Annuloplasty Device in the U.S. by doctors at the West Virginia University (WVU) Heart and Vascular Institute in Morgantown, West Virginia. Drs. Lawrence Wei, Vinay Badhwar and J. Scott Rankin were the […]
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The […]
GENT, Belgium, Sept. 22, 2017 — FEops, a leader in personalized computer modeling for structural heart interventions, announced it has secured a 6 million euros investment, led by Valiance, and joined by existing investors Capricorn and PMV. The funding will be used to aggressively implement the company’s product roadmap, centered […]
DUBLIN – September 21, 2017 – Medtronic plc (NYSE: MDT) today announced a new post-market clinical study to evaluate its CoreValve(TM) Evolut(TM) PRO valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery, the FORWARD PRO Clinical Study […]
DANVERS, Mass., Sept. 20, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP® heart pump. Culminating from five years of research, this approval follows the […]
SAN DIEGO, Sept. 20, 2017 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) announced today that its Board of Directors has appointed Ray Larkin Jr., a current member of the Company’s Board of Directors, as Chairman of the Board, effective September 18, 2017. Mr. Larkin replaced Brian […]
DALLAS & SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the University of Miami Miller School of Medicine and co-sponsored by the company. The results showed a […]
