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. […]
Other News
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 […]
InspireMD Announces Issuance of Two New U.S. Patents Covering Proprietary MicroNet™ Stent Jacket and Related Drug Eluting Technology
TEL AVIV, Israel, Sept. 17, 2018 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that the United States Patent and Trademark Office (USPTO) has issued US Patents […]
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 […]
First Patient in Europe Receives Implant of GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System and Enrolls in Post-Market Registry
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) today announced the first European patient implant of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System. This next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms (AAA) in patients with challenging anatomies. […]
Audio: Denis Harrington, CEO of NexGen Medical Systems speaks with CardiacVascularNews
Audio recording: Learn more about NexGen Medical System and the XCOIL System to remove blood clots from their CEO, Denis Harrington recorded at his office in Wayzata, MN.
