Coronary/Structural Heart

ARCA biopharma Submits Special Protocol Assessment Request to FDA for Gencaro Phase 3 Atrial Fibrillation Clinical Trial

WESTMINSTER, Colo., Sept. 18, 2018 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA).  The request is part of the […]

Boston Scientific Announces Scheduled Presentations At Transcatheter Cardiovascular Therapeutics 2018

MARLBOROUGH, Mass., Sept. 17, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE :BSX ) today announced key data that will be presented at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in San Diego, on September 21 – September 25. Data from the head-to-head IMPERIAL trial evaluating the ELUVIA™ […]

DiA Imaging Analysis’ AI-Powered LVivo EF Cardiac Tool Now Available for the GE Healthcare Vscan Extend™ Handheld Mobile Ultrasound

BE’ER SHEVA, Israel, and HARTFORD, Conn., Sept. 18, 2018 /PRNewswire/ — DiA Imaging Analysis Ltd. (DiA), a provider of artificial intelligence (AI)-powered ultrasound analysis tools, announced today that its LVivo EF cardiac decision-support software is now available for purchase for GE’s new Vscan Extend™ handheld, pocket-sized ultrasound. This collaboration is an outgrowth of work between DiA […]

Medtronic Announces Clinical Study of Transcatheter Aortic Valve Replacement in Aortic Stenosis Patients with Bicuspid Valves

DUBLIN – September 18, 2018 – Medtronic plc (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a single-arm study to evaluate the CoreValve Evolut(TM)TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. […]

LivaNova Launches International Pivotal Study Evaluating Use of Autonomic Regulation Therapy for Heart Failure

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced the first successful implantation of the VITARIA® System in a patient enrolled in the Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction (ANTHEM-HFrEF) Pivotal Study. The study is an international, multi-center, randomized trial to evaluate the VITARIA System for the […]

Saranas™ Announces Initial Clinical Cases with the Early Bird™ Bleed Monitoring System

HOUSTON–(BUSINESS WIRE)–Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, announced that the first clinical cases with Early Bird Bleed Monitoring System were performed at Atlantic Health System’s Morristown Medical Center (Morristown, NJ). The cases varied across multiple interventions […]

Freudenberg Medical Presents New Catheter Handle Platform and Steerable Introducer Products at Transcatheter Cardiovascular Therapeutics 2018

JEFFERSONVILLE, Ind.–(BUSINESS WIRE)–Freudenberg Medical, a global developer and manufacturer of finished medical devices and subassemblies, components, and minimally invasive solutions for the medical device industry, announced several new options for medical device companies looking to accelerate time to market. The new Composer®XL Deflectable Catheter Handle Platform provides a commercialization ready […]

CareDx broadens HeartCare availability

BRISBANE, Calif., Sept. 17, 2018 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA), a molecular diagnostics company focused on the discovery, development, and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today announced the launch of the Surveillance HeartCare® Outcomes Registry (SHORE). CareDx will launch SHORE during the 22nd Annual […]

Tasly Pharmaceutical Group Receives All Necessary Approvals for Transaction With Mesoblast

NEW YORK and MELBOURNE, Australia, Sept. 17, 2018 (GLOBE NEWSWIRE) — Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced that Tasly Pharmaceutical Group has successfully obtained all necessary approvals, including the Safe Administration of Foreign Exchange, required for closing the investment agreement and the development and collaboration agreement with Mesoblast […]

New Study Confirms Significant Potential U.S. Market for Hancock Jaffe’s VenoValve®

IRVINE, Calif., Sept. 17, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, has commissioned a research report from The Sage Group, a research organization specializing in peripheral vascular disease. The report, titled “Chronic Venous Disease: Epidemiology […]