The Latest Cardiac and Vascular News
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the first two patients in the world have been treated with the Abiomed Breethe OXY-1 System, a compact cardiopulmonary bypass system. The advanced ECMO technology pumps, oxygenates, and removes carbon dioxide from blood for patients whose lungs can no longer provide sufficient end organ oxygenation. The […]
TricValve® made in Europe VIENNA, Dec. 22, 2020 /PRNewswire/ — P+F Products + Features GmbH has been granted designation as a Breakthrough Device for the company’s lead product, the TricValve® Transcatheter Bicval Valves System by the U.S. Food & Drug Administration on December 15th 2020. The TricValve® is a system of two self-expanding biological valves for […]
Collaboration Strengthens Peijia’s Position for Competing in a Largely Untapped Market and Supports Global Expansion of HighLife’s Technology SUZHOU, China and PARIS, Dec. 20, 2020 /PRNewswire/ — Peijia Medical Ltd (HK Stock Code: 09996) and HighLife SAS, a Paris-based medical device company, focused on the development of a unique transeptal mitral valve replacement (“TMVR”) system to treat […]
IRVINE, Calif., Dec. 21, 2020 /PRNewswire/ — Edwards Lifesciences (NYSE: EW), today announced that the first patient has been treated in the RESTORE clinical trial, which will evaluate the safety and effectiveness of the investigational HARPOON Beating Heart Mitral Valve Repair System in the United States and Canada. The HARPOON system uses a less-invasive technique than open-heart […]
HANGZHOU, China, Dec. 21, 2020 /PRNewswire/ — On December 15, 2020, Professor Wang Jian‘an’s team from the Second Hospital of Zhejiang University School of Medicine successfully applied the DragonFly-T™ Transcatheter Tricuspid Valve Clamping System to perform the first human clinical application in mainland China. This is the first self-developed product for trans-femoral tricuspid regurgitation […]
GENT, Belgium–(BUSINESS WIRE)–FEops, a digital health leader in personalized predictive planning for structural heart interventions, is proud to announce the new release of FEops HEARTguideTM. This includes the full range of the Boston Scientific WATCHMAN FLX™ devices, enhanced visualization for the prediction of paravalvular leak (PVL) and conduction abnormalities (CA) for […]
– Abbott’s HeartMate 3™ heart pump approved for use for pediatric patients battling advanced heart failure – This life-saving technology provides new treatment option for underserved population ABBOTT PARK, Ill., Dec. 17, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the […]
SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ — Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH affects hundreds of thousands in the U.S. and globally and […]
Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced that its positive results of the interim analysis of Recardio’s Phase II clinical trial in AMI were published in the latest release of the European Heart Journal. The current version of the journal relates to the presentation […]
TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed […]
