The Latest Cardiac and Vascular News
– NILEMDO® (bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients – – Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies1,2 – […]
WEBSTER, Texas, Dec. 16, 2020 /PRNewswire/ — Corvion – developer of fully implanted mechanical circulatory support devices – announced today that it has received Breakthrough Device Designation for its fully implanted Left Ventricular Assist Device (LVAD) from the FDA. The designation will allow the company to interact with the FDA’s experts to […]
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of […]
LIVERMORE, Calif., Dec. 16, 2020 /PRNewswire/ — Advanced Bifurcation Systems, Inc. (ABS), a Livermore, CA-based maker of the ABS System, a proprietary stent delivery system that is specifically designed to efficiently treat coronary bifurcation lesions, is pleased to announce the first closing of an $11 million Series A equity financing. The round was led by […]
EDEN PRAIRIE, Minn., Dec. 15, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, today announced a meta-analysis published in Heart Failure Reviews concludes that ultrafiltration (UF) increases fluid removal and weight loss and reduces rehospitalization and the […]
VANCOUVER and MINNEAPOLIS, Dec. 15, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) announced today that it has completed the first three Neovasc Reducer™ (“Reducer”) implants in France. The implants are an important step for Neovasc as the Company continues to expand access for Reducer therapy to […]
rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccines rNAPc2 is the only novel compound being developed for COVID-19 Associated Coagulopathy Topline trial data anticipated in the second quarter of 2021 Data from this development program will also inform potential development in […]
NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced top-line results from the landmark DREAM-HF Phase 3 randomized controlled trial of its allogeneic cell therapy rexlemestrocel-L (REVASCOR®) in 537 patients with advanced chronic heart failure1. Over […]
NEW YORK, Dec. 15, 2020 /PRNewswire/ — Elysium Health, Inc.,TM a life sciences company developing clinically validated health products based on aging research, today announced the initiation of a Phase II clinical trial at Mayo Clinic to evaluate the efficacy of BASISTM for the prevention of acute kidney injury (AKI) in patients that have undergone a cardiac […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will […]
