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 […]
Coronary/Structural Heart
Advanced Bifurcation Systems Announces First Closing Of Series A Financing
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 […]
CHF Solutions Announces Meta-Analysis Demonstrates Ultrafiltration is Better than Diuretic Therapy for the Management of Volume Overload in ADHF
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 […]
Neovasc Announces First Neovasc Reducer™ Implants in France
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 […]
ARCA biopharma Announces First Patients Enrolled in ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 (AB201) as a Potential Treatment for COVID-19
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 […]
Mesoblast Provides Topline Results From Phase 3 Trial of Rexlemestrocel-L for Advanced Chronic Heart Failure
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 […]
Elysium Health™ Announces Initiation of Phase II Clinical Trial at Mayo Clinic to Evaluate BASIS™ for Prevention of Acute Kidney Injury After Cardiac Surgery
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 […]
Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve
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 […]
BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial
SAN CARLOS, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA)(BioCardia or the “Company”) today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Phase 3 CardiAMP Heart Failure Trial that is currently enrolling […]
New JAMA Network Open Publication Demonstrates the Coronary CT- HeartFlow Analysis Pathway Is ‘Dominant’ Compared to Stress Testing in Cost-Effectiveness Analysis
REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc., a leader in revolutionizing precision heartcare, announced that a new cost-effectiveness analysis found a diagnostic pathway which utilizes coronary computed tomography angiography (CTA) with the HeartFlow FFRct Analysis to be “dominant” (less costly and more effective) as compared to stress testing for assessing patients with […]
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