The Latest Cardiac and Vascular News
IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with […]
CRESSKILL, N.J., Sept. 9, 2019 /PRNewswire/ — Vascular Therapies, a clinical stage biotechnology company, is developing Sirogen™, a proprietary sirolimus formulation for intraoperative local, perivascular drug delivery focused on improving vascular access outcomes in patients with kidney disease. Daniel G. Clair, MD, vascular surgeon and Chairman of the Department of Surgery at Palmetto Health-USC […]
LIMERICK, Ireland–(BUSINESS WIRE)–Cook Medical is pleased to announce that Beacon® Tip Catheters are once again available to physicians in Europe. As of September 2019, the catheters are available in the UK, Ireland, Norway, Sweden, Finland, Denmark, Germany, Poland, the Netherlands, Luxembourg, Belgium, France, Switzerland, Austria, Hungary, Spain and Italy. Cook is […]
TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure. The FDA received Concept […]
Study designed to evaluate safety, efficacy of the company’s next-generation SurVeil™ drug-coated balloon Company Raises 2019 Revenue and EPS Guidance EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has completed enrollment in TRANSCEND, […]
Ascyrus Medical receives Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. BOCA RATON, FLA. (PRWEB) AUGUST 14, 2019 Ascyrus Medical announced today that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) […]
Company introduces Diamondback 360° Exchangeable Series to treat multi-level PAD ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the three-year outcomes from its LIBERTY 360° study will […]
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first ‘Breakthrough Device Designation’ received by Concept Medical […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a new pivotal study to evaluate the safety and effectiveness of the Nellix […]
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that it has acquired the WIRION Embolic Protection System and related assets from Gardia Medical Ltd., a wholly owned Israeli […]
