Coronary/Structural Heart

CARMAT Announces the Completion of Its Investigations on Previously Identified Quality Issues

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the completion of investigations on its prostheses. Following the occurrence of […]

FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

– With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction(1) – Leqvio provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain people with atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statin […]

Claritas to Develop R-107 for Treatment of PPHN, a Potentially Fatal Pulmonary Disorder in Newborns

SAN FRANCISCO, CA, and TORONTO, ON, Dec. 22, 2021 (GLOBE NEWSWIRE) — Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the “Company” or “Claritas“) today announced that it will develop R-107 for the treatment of persistent pulmonary hypertension of the newborn (“PPHN”). PPHN is fatal in up to 50% of newborn patients […]

Alnylam Comments on FDA Approval of Leqvio®, the First siRNA (RNAi Therapeutic) Approved to Reduce LDL-C

– Leqvio® Becomes Fourth RNAi Therapeutic Approved by U.S. FDA and First and Only for Lowering LDL-C in Atherosclerotic Cardiovascular Disease (ASCVD) Which Can Affect Up to 30 Million Americans – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today highlighted the significance of the U.S. Food and […]

First Clinical Study on TRIA Biopolymer Heart Valve Shows Excellent One-Year Performance

Publication in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions Found TRIA Aortic Heart Valve Provided Sustained Improvement in Heart Valve Function to One-Year with Good Safety Profile SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced publication of the first clinical results for its TRIA™ biopolymer heart valve – […]

St. Joseph’s Children’s Hospital First in Florida to Use Breakthrough Device for Non-Surgical Pulmonary Valve Replacement

The revolutionary Harmony Transcatheter Pulmonary Valve is placed via cardiac catheterization and provides an alternative to open-heart surgery for patients with leaky pulmonary valves. TAMPA, Fla., Dec. 20, 2021 /PRNewswire/ — Jasmine Harvey, 21, was born with the complex congenital heart condition tetralogy of Fallot and underwent open-heart surgery at St. Joseph’s Children’s Hospital when she […]

Mezzion Pharma Announces Positive Data Presented to FDA in Type C Meeting

SEOUL, South Korea and BETHESDA, Md., Dec. 21, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of a very large subgroup of patients with congenital single ventricle […]

PhaseBio Provides Pemziviptadil (PB1046) Program Update

Phase 2b trial of pemziviptadil in pulmonary arterial hypertension (PAH) voluntarily ended early by the Company in order to evaluate existing program data and determine next steps forward Company to reprioritize resources and capital towards successful commercialization of bentracimab and advancement of other pipeline programs MALVERN, Pa. & SAN DIEGO–(BUSINESS […]

Vifor Pharma reports positive outcome of the phase-IIIb DIAMOND trial of Veltassa®

Phase-IIIb trial demonstrates statistically significant outcome on the primary endpoint Largest study to date showing benefit of Veltassa® (patiromer) in high risk patient population with heart failure Results suggest that treatment with Veltassa® is beneficial in heart failure patients to control serum potassium levels Veltassa® enabled 85% of patients to be optimized to […]

Edwards Receives FDA Approval for SAPIEN 3 with Alterra Prestent for Transcatheteter Pulmonic Valve Replacement

IRVINE, Calif., Dec. 20, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced it received approval from the U.S. Food and Drug Administration (FDA) for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for patients with severe pulmonary regurgitation. The Edwards SAPIEN 3 […]