Coronary/Structural Heart

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 […]

Acceleron Receives Orphan Designation from the European Commission (EC) for Sotatercept in Pulmonary Arterial Hypertension (PAH)

– Sotatercept received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in PAH in 2019 – – In the spring of 2020, sotatercept received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), both in PAH – December 14, […]

Amarin Highlights Multiple VASCEPA® (Icosapent Ethyl)-Related Scientific Findings Presented at National Lipid Association (NLA) Scientific Sessions 2020, Including First COVID-19 Clinical Results

REDUCE-IT® EPA Encore Presentation reinforces Eicosapentaenoic Acid (EPA) levels from VASCEPA® (icosapent ethyl) strongly correlated to cardiovascular outcomes, more so than other biomarkers VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in outpatient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with […]

ABBOTT LAUNCHES FIRST OPTICAL COHERENCE TOMOGRAPHY VIRTUAL REALITY TRAINING PROGRAM FOR CARDIOLOGISTS

Virtual reality training improved cath lab staff learning engagement by 45% and knowledge retention by 72% 87% of studies show higher medical accuracy in medical practice by those trained with virtual reality ABBOTT PARK, Ill., Dec. 9, 2020 — Abbott today announced the global release of its first virtual reality-based […]