The Latest Cardiac and Vascular News
IRVINE, Calif., Dec. 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients […]
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the first patients in the United States were treated using the OrbusNeich® Teleport Microcatheter (Teleport), which recently received U.S. Food […]
HANGZHOU, China and CAESAREA, Israel and TAMPA, Fla., Dec. 26, 2018 /PRNewswire/ — Venus Medtech (Hangzhou) Inc., the preeminent Chinese transcatheter heart valve company, today announced it has closed its Merger with Keystone Heart Ltd., a privately-held medical device company and makers of TriGUARD 3™. The Merger provides Venus Medtech with TriGUARD 3, the first Cerebral Embolic Protection Device designed […]
KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial […]
LAVAL, Québec, Dec. 20, 2018 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), today announced it has reached […]
BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced that it received clearance by the Food and Drug Administration (FDA) for a design enhancement allowing for the use of the Paragonix SherpaPak™ Cardiac Transport System (CTS)1,2 with small and pediatric donor hearts. Starting in Q1 2019, Paragonix SherpaPak™ CTS will now be shipped with […]
LONDON and MONTREAL, Dec. 17, 2018 (GLOBE NEWSWIRE) — DalCor today announced the completion of patient enrollment in the dal-GenE study, the first Phase 3 precision medicine cardiovascular outcomes trial in coronary heart disease. The dal-GenE study is evaluating the efficacy of the CETP inhibitor dalcetrapib to reduce clinical cardiovascular […]
GALWAY, Ireland–(BUSINESS WIRE)–WhiteSwell, a company pioneering new ways to treat acute decompensated heart failure, today announced the close of a $30 million series B funding round led by RA Capital Management and an InCube Ventures syndicate, with participation from other investors. Funds from the round will be used to support […]
ALAMEDA, Calif.–(BUSINESS WIRE)–Singulex announced today the granting of a significant European patent (EP 3168618) covering methods for determining myocardial infarction using any high sensitivity cardiac troponin assay with a sensitivity < 5 pg/mL. “The global clinical market is rapidly adopting high sensitivity cardiac troponin assays to better manage patients suspected […]
MARLBOROUGH, Mass., Dec. 11, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences’ Sapien 3™ Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages […]
