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 […]
Other News
Cardiovascular Startup, Filterlex Medical, Selected to Receive €7M from the European Innovation Council
Equity investment to support advancement of its breakthrough full-body embolic protection device to reduce the risk of stroke and other complications during left-heart procedures. CAESAREA, Israel, Dec. 21, 2021 /PRNewswire/ — Filterlex Medical, a cardiovascular medical device startup, announced today that it has been selected to receive €7 Million equity investment from the European […]
CHILDREN’S HOSPITAL COLORADO FIRST PEDIATRIC HOSPITAL TO TREAT PATIENTS USING 3D INTRACARDIAC ECHOCARDIOGRAPHY CATHETER
3D ICE improves standard of care for congenital heart disease and electrophysiology procedures by reducing need for general anesthesia, improving efficiency and expanding treatment options AURORA, Colo., Dec. 20, 2021 /PRNewswire/ — Children’s Hospital Colorado (Children’s Colorado) is the first pediatric hospital in the world to use a 3D intracardiac echocardiography (ICE) catheter […]
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 […]
First U.S. patients with persistent cardiac arrythmias treated using Volta Medical’s artificial intelligence-based analysis
Novel, FDA-cleared and CE-certified medical device is designed to help cardiologists identify cardiac abnormalities in patients undergoing ablation treatment for persistent, drug-resistant atrial fibrillation (AF), a common heart condition. New York-Presbyterian Queens, Northwell Health’s Lenox Hill Hospital, New York City, and Ascension St. Vincent’s Riverside, Jacksonville, Fla. are the first […]
BioSig Technologies, Inc. Selects Access Strategy Partners to Accelerate Commercial Sales
Leading healthcare management firm to enhance the Company’s market access strategy as it expands the installation base of its signal processing technology for arrhythmia care Westport, CT, Dec. 21, 2021 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal […]
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 […]
Affera Announces First Patient Treated in SPHERE Per-AF IDE Trial
First enrollment comes as investors provide $75M toward an oversubscribed Series C financing NEWTON, Mass., Dec. 20, 2021 /PRNewswire/ — Affera Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that the first patient was treated in the recently approved SPHERE PerAF Trial, a U.S. Food and […]
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 […]



