The Latest Cardiac and Vascular News
ATLANTA, Feb. 7, 2020 /PRNewswire/ — CorMatrix®Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced receiving FDA approval to expand and enroll 20 additional patients in the adult arm, including up to 4 additional cardiac surgery research and investigative centers, for its early feasibility IDE study of the Cor® TRICUSPID ECM® valve* for […]
DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 06, 2020 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), announced today that BioNJ awarded Amarin with an Innovator Award in recognition of the approval of a new indication for VASCEPA® (icosapent ethyl) by the U.S. Food and Drug Administration (FDA) in December 2019. This […]
SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced it received renewal of the highest priority reimbursement in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System by achieving the NUB Status 1 designation from InEk, the German […]
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 […]
