Coronary/Structural Heart

REVA Announces First Implant of the Fantom Encore Bioresorbable Scaffold in Italy

SAN DIEGO, Dec. 03, 2018 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX: RVA) (“REVA” Or The “Company”), a leader in bioresorbable polymer technologies for vascular applications, announced the first implant of its recently launched Fantom Encore bioresorbable scaffold (BRS) in Italy. The implant procedure was performed by Professor Antonio Colombo at […]

Hancock Jaffe Announces January CoreoGraft Study at the Texas Heart Institute

IRVINE, Calif., Dec. 04, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that it will begin a feasibility study for its CoreoGraft bioprosthetic graft on January 29th at the Texas Heart Institute.  The pre-clinical […]

Atlantic Health System’s Morristown Medical Center Performs World’s First Catheter-Based Mitral Valve Repair in CLASP IID Pivotal Trial

MORRISTOWN, N.J., Dec. 3, 2018 /PRNewswire/ — Atlantic Health System’s Morristown Medical Center today announced that its internationally recognized cardiac team performed the world’s first transcatheter mitral valve repair (TMVr; a minimally invasive, catheter-based procedure to repair the heart’s mitral valve) in the CLASP IID Pivotal Trial. The CLASP IID Trial led […]

JenaValve Technology Receives FDA Approval for Expanded IDE Enrollment in the Treatment of Patients with Severe Aortic Stenosis and Severe Aortic Regurgitation

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur™ transcatheter heart valve (THV) and […]

Conformal Medical Announces $9 million Series B Financing

NASHUA, N.H., Dec. 3, 2018 /PRNewswire/ — Conformal Medical, Inc., developer of the Conformal Left Atrial Appendage Seal for LAA occlusion, has secured $9 million in Series B funding. Conformal is developing proprietary seal technology for the prevention of stroke in patients with atrial fibrillation (AFib). Over five million people in the United States have AFib, […]

Micro Interventional Devices, Inc.™ Announces Continued Successful Enrollment in STTAR Trial

NEWTOWN, Pa., Nov. 29, 2018 /PRNewswire/ — Micro Interventional Devices, Inc.™ (MID) announced the continued successful enrollment of patients in STTAR (the Study of Transcatheter Tricuspid Annular Repair) being conducted in Europe.   MID’s MIA™, Minimally Invasive Annuloplasty technology, is being studied for its safety and performance in the treatment of severe tricuspid regurgitation.  MIA […]

Edwards Lifesciences and Medtronic Lead the U.S. TAVR Market, Despite Threat of New Competition – New Analysis from iData Research

VANCOUVER, British Columbia–(BUSINESS WIRE)–According to a new series of reports by iData Research, the United States cardiac surgery device market is valued at $5.7 billion USD and is forecast to exceed $10 billion by 2024. The largest segment of the cardiac surgery market is the transcatheter heart valve replacement (THVR) […]

Edwards’ SAPIEN 3 Ultra Transcatheter Heart Valve Receives CE Mark

IRVINE, Calif., Nov. 16, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients. “The SAPIEN 3 Ultra […]

CHF Solutions Launches Educational Webinar Discussing the Benefits of Aquadex FlexFlow® Therapy Following Cardiovascular Surgery with Cardiovascular Surgeon, Daniel Beckles, M.D., Ph.D.

EDEN PRAIRIE, Minn., Nov. 15, 2018 (GLOBE NEWSWIRE) — CHF Solutions, Inc. (Nasdaq: CHFS), today announces the launch of its new educational webinar featuring Daniel Beckles, M.D., Ph.D., director of Minimally Invasive Cardiothoracic Surgery at UHS Heart and Vascular Institute, Vestal, N.Y.  The webinar can be accessed on the company’s […]

Terumo Cardiovascular Group Announces 510(k) Clearance for the CDI® Blood Parameter Monitoring System 550, Adding New Parameter for Oxygen Delivery

ANN ARBOR, Mich., Nov. 14, 2018 /PRNewswire/ — Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time monitoring of oxygen delivery as one of 12 critical blood parameters. Oxygen […]