The Latest Cardiac and Vascular News
Paragonix SherpaPak™ Cardiac Transport System is the only FDA-cleared and CE-marked device that safeguards hearts between donor and recipient patients CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced that the first series of pediatric donor hearts preserved and transported using Paragonix SherpaPak Cardiac Transport System occurred at University of Florida Health (UF […]
ZURICH–(BUSINESS WIRE)–Inositec, a pioneer in the development of life-saving small molecule drugs based on myo-inositol hexaphosphate (IP6), announced today that positive proof-of-concept data on INS-3001, a novel cardiovascular calcification inhibitor, were published in Nature Communications (DOI: 10.1038/s41467-019-14091-4). INS-3001 was found to be a potent and well tolerated inhibitor of pathological soft tissue calcification […]
ABBOTT PARK, Ill., Feb. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Implantable Left Ventricular Assist System (FILVAS). The FDA launched the Breakthrough Devices Program in 2018 to help expedite the development and review […]
SPYRAL DYSTAL Study to Evaluate the Effects of RDN Using Fewer, Targeted Ablations to Achieve Meaningful Blood Pressure Reductions DUBLIN, Feb. 04, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity™ Spyral renal denervation (RDN) system […]
QSP Modeling Project Targeted at Prevention of Heart Failure RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–DILIsym Services Inc. (DSS), a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical efficacy and safety, today announced that it is developing a new component for a QSP model […]
CALGARY, Alberta, Feb. 03, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX) is pleased to announce the U.S. Food & Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for apabetalone in combination with top standard of care, including high-intensity statins, for the secondary prevention of major […]
NEW YORK, Feb. 03, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it has submitted its completed Biologics License Application (BLA) to the United States Food and Drug Administration (US FDA) for Ryoncil™ (remestemcel-L), its lead allogeneic cell therapy […]
CorCinch HFrEF Study Evaluating Safety of AccuCinch Ventricular Repair System in Heart Failure Patients SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of enrollment in its CorCinch HFrEF […]
VANCOUVER, Jan. 31, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that the Institut für […]
– Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet is an Oral, Once-Daily, Non-Statin Medicine that Lowers Bad Cholesterol with a First-in-Class Mechanism – – Positive CHMP Opinion is Based on the Completed Pivotal Phase 3 Fixed Dose Combination Tablet LDL-Cholesterol Lowering Program – – European Commission Decision on the Marketing Authorisation Application […]
