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, […]
Author: Ken Dropiewski
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 […]
Aziyo Launches CanGaroo Bio Envelope for Subcutaneous Implantable Cardioverter-Defibrillators
SILVER SPRING, Md.–(BUSINESS WIRE)– Aziyo Biologics, a fully integrated regenerative medicine company, today announced the launch of a new CanGaroo Bio Envelope specifically for use with subcutaneous implantable cardioverter-defibrillators (S-ICDs). This is the only cardiac implantable electronic device (CIED) envelope available for use with S-ICDs. CanGaroo is a natural extracellular matrix (ECM) scaffold that […]
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 […]
BioCardia Announces Reverse Stock Split and Release of Indemnity Holdback Shares
SAN CARLOS, Calif.–(BUSINESS WIRE)– BioCardia, Inc.[OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced a reverse split of its common stock, $0.001 par value, at a ratio of 1 for 12, effective November 2, 2017 (the “Effective Date”). The company’s common stock will begin […]
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 […]
Five-year Follow-up Data Demonstrate the WATCHMAN™ Left Atrial Appendage Closure Device Provides Stroke Risk Reduction Comparable to Warfarin Therapy
DENVER and MARLBOROUGH, Mass., Nov. 2, 2017 /PRNewswire/ — Boston Scientific (NYSE: BSX) announced final five-year outcomes data from the PREVAIL study of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device today during a late-breaking clinical trial session at the 29th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Denver. The […]
Imricor and MiRTLE Medical Announce Joint Development Agreement to Deliver 12-Lead ECG for Real-Time MRI-Guided Cardiac Ablations
MINNEAPOLIS–(BUSINESS WIRE)–Imricor and MiRTLE Medical announce a joint development agreement to fully integrate MiRTLE’s MR compatible 12-lead ECG system with Imricor’s Advantage-MR™ EP Recorder/Stimulator System. This integration, along with Imricor’s MR compatible catheters, will allow physicians to perform complex cardiac ablations, such as for treating ventricular tachycardia and atrial fibrillation, under real-time MRI-guidance. […]
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, […]



