Technology Anticipated to Impact Cardiac Biologic Therapies, Cardiac Arrhythmia, and Structural Heart Procedures SAN CARLOS, Calif., Dec. 30, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of U.S. Patent No: 10,874, 831 for “Devices and Methods for […]
Coronary/Structural Heart
CARMAT Receives the CE Marking for Its Total Artificial Heart
CE marking allows the company to market its total artificial heart in the EU as a bridge to transplant Virtual press conference scheduled on January 6, 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an […]
Cytokinetics Regains European Rights to Omecamtiv Mecarbil
Company is Planning Regulatory Interactions in 2021 to Discuss Results of GALACTIC-HF and Expects to Evaluate Strategic Options for Co-Commercialization and Licensing SOUTH SAN FRANCISCO, Calif., Dec. 23, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) announced that Amgen Inc. (“Amgen”) notified the company that Les Laboratoires Servier and Institut […]
First Patients, Including a COVID-19 Patient, Treated with Abiomed’s Innovative ECMO Technology
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® Transcatheter Bicaval Valves System granted Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA)
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 […]
Peijia Medical and HighLife Enter Into License and Technology Transfer Agreement for Transeptal Mitral Valve Replacement in Greater China
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 […]
Edwards Treats First Patient In U.S. Clinical Trial Evaluating Minimally Invasive Device For Mitral Valve Disease
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 […]
Major Breakthrough: DragonFly-T™ First Transcatheter Tricuspid Valve Repair Surgery in China
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 […]
Extended FEops HEARTguide™ Offering Now Available
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 […]
FDA Approves Labeling Update for Abbott’s HeartMate 3 Heart Pump for use in Pediatric Patients
– 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 […]
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