VASCEPA becomes the first and only Health Canada approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients approved for treatment Commercial launch expected in mid-February 2020 by Amarin’s commercial partner for Canada VASCEPA approval was supported by clinical results from the REDUCE-IT® trial which included […]
Coronary/Structural Heart
Neovasc Submits Premarket Approval Application to FDA for Neovasc Reducer™
VANCOUVER, Dec. 31, 2019 (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 the submission of a Premarket […]
CryoLife Receives FDA Authorization to Commence PROACT Xa Clinical Trial
Study Designed to Evaluate the Use of Apixaban in On-X Aortic Valve Patients ATLANTA, Dec. 23, 2019 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has received authorization from the U.S. Food and Drug Administration (FDA) pursuant to an Investigational New […]
Acasti Pharma Provides Update on Timing of Topline Results for TRILOGY 1 Phase 3 Trial of CaPre
Expects to report Trilogy 1 topline results in January 2020 with topline results for Trilogy 2 still expected by the end of January 2020 LAVAL, Québec, Dec. 23, 2019 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the […]
Quantum Genomics Initiates its Pivotal Phase III FRESH Trial in Difficult-to-Treat and Resistant Hypertension
PARIS and NEW YORK, Dec. 19, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC, OTCQX – QNNTF), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the initiation of its pivotal Phase III FRESH study […]
Medicure Announces the Completion of Shortened AGGRASTAT® Versus Integrilin® in Percutaneous Coronary Intervention (SAVI-PCI) Study
WINNIPEG, Dec. 17, 2019 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the completion of the Shortened AGGRASTAT® (tirofiban hydrochloride) injection versus Integrilin® (eptifibatide) in Percutaneous Coronary Intervention (SAVI-PCI) Clinical Trial. SAVI-PCI was a randomized, multicenter, open-label study enrolling 535 patients at 13 sites […]
TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure
NANJING, China, Dec. 16, 2019 /PRNewswire/ — TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for TT-00920, a novel small molecule inhibitor of Phosphodiesterase 9 (PDE 9) for the treatment of chronic heart failure. […]
Neovasc Reducer™ Featured In National Geographic Magazine
VANCOUVER, Dec. 17, 2019 (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, announced today that the Neovasc Reducer™ (the […]
Mesoblast’s Phase 3 Trial of Revascor in Advanced Chronic Heart Failure Surpasses the Number of Primary Endpoint Events for Trial Completion
NEW YORK, Dec. 17, 2019 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that its Phase 3 trial of Revascor for advanced chronic heart failure has surpassed the number of primary endpoint events required for trial completion. This cardiovascular outcomes trial has now initiated final study visits […]
Novoheart Licenses Harvard Technology to Develop Next-Generation Human Heart-in-a-Jar
Novoheart engineered the world’s first “human heart-in-a-jar” as part of its proprietary MyHeart™ platform Novoheart receives exclusive license from Harvard University to integrate pioneering bioreactor technology that accommodates model ventricles and optional valves into the “human heart-in-a-jar” model The resultant next-generation model will have unparalleled biofidelity as well as enhanced […]
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