Coronary/Structural Heart

CryoLife Announces Enrollment of First Patients in BioGlue Clinical Trial in China

ATLANTA, Nov. 6, 2017 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY),a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that enrollment has started in the Company’s BioGlue clinical trial in China. The results from the trial will serve as the basis of the Company’s regulatory submission […]

HeartFlow Announces Decision by Centers for Medicare & Medicaid Services to Assign a New Technology Payment Classification to HeartFlow® FFRct Analysis

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that the Centers for Medicare & Medicaid Services (CMS) has finalized a New Technology Ambulatory Payment Classification (APC) for the HeartFlow® FFRct Analysis, a first-of-its-kind non-invasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). Under the APC payment system, […]

ABBOTT’S MITRACLIP APPROVED AS FIRST TRANSCATHETER MITRAL VALVE REPAIR DEVICE IN JAPAN

ABBOTT PARK, Ill., Nov. 6, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the company’s MitraClip device for treatment of people with mitral regurgitation (MR), a serious, progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward […]

Neovasc Jumps on FDA Nod for Clinical Trial

VANCOUVER, Nov. 6, 2017 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company“) (NASDAQ, TSX: NVCN) announced that it has received approval of the U.S. Food and Drug Administration (“FDA”) to initiate the COSIRA-II IDE pivotal clinical trial.  The trial’s purpose will be to demonstrate the safety and effectiveness of the Company’s novel Reducer system […]

Mitralign Release: SCOUT I Study Using Trialign System for Transcatheter Tricuspid Repair Continues to Show Positive Outcomes at 1 Year

DENVER–(BUSINESS WIRE)– Mitralign, Inc.., an innovative developer of transcatheter tricuspid and mitral valve repair solutions, today released 1 year follow up data from the SCOUT I Early Feasibility Study designed to evaluate the performance of its Trialign™ System. The data presented by Rebecca Hahn, M.D., New York-Presbyterian/Columbia University Medical Center, continue […]

Medtronic Evolut(TM) PRO TAVR System with Advanced Sealing Maintains Excellent Outcomes Over Time

DUBLIN and DENVER – November 2, 2017 – Medtronic plc (NYSE:MDT) today presented new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting showcasing the excellent clinical performance of the Evolut(TM) Transcatheter Aortic Valve Replacement (TAVR) platform. Six-month data from the newest-generation Evolut PRO System demonstrated continued benefits of its unique valve […]

4C Medical’s Novel Transcatheter Mitral Valve Presented at TCT 2017 Shark Tank Innovation Competition

BROOKLYN PARK, Minn., Nov. 2, 2017 /PRNewswire/ — 4C Medical Technologies, Inc., a developer of minimally invasive technologies for structural heart disease, today announced that its medical device for mitral regurgitation (MR) was presented at the Shark Tank Innovation Competition at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held October 29-November 2, […]

Medtronic Shows Off Early Intrepid TMVR Data

DUBLIN and DENVER – November 1, 2017 – Medtronic (NYSE:MDT) today presented positive data for its self-expanding Intrepid(TM) transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation. Presented as a First Report Investigation at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting and simultaneously published in the Journal of the American […]