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 […]
Coronary/Structural Heart
Elucid Announces American Medical Association (AMA) Instates CPT Code for Lipid-Rich Necrotic Core Quantification to Assess Atherosclerotic Plaque Stability
Quantification of the structure and composition of the vessel wall and assessment of lipid-rich necrotic core plaque (CPT 0710T-0713T) BOSTON–(BUSINESS WIRE)–Elucid, a Boston-based medical technology company harnessing scientific imaging and artificial intelligence to enable the precise diagnosis and treatment of the world’s leading cause of death announced a new CPT […]
BioMarin and Skyline Therapeutics Announce Strategic Collaboration to Develop Novel Gene Therapies for Cardiovascular Diseases
SAN RAFAEL, Calif. and SHANGHAI, Dec. 16, 2021 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Skyline Therapeutics (formerly Geneception), a gene and cell therapy company focused on developing novel treatments for unmet medical needs, today announced a multi-year global strategic collaboration for the discovery, development and commercialization of Adeno-Associated Virus (AAV) gene therapies to […]
Thubrikar Aortic Valve Announces Authorization to Initiate Patient Implants Toward CE Mark Approval of Optimum TAV™, and Development of Its Novel Precision 2™ Delivery Catheter
NORRISTOWN, Pa.–(BUSINESS WIRE)–Thubrikar Aortic Valve, Inc., announced today that it received approval from a Competent Authority in Poland to conduct initial patient implants with its Optimum Transcatheter Aortic Valve Implantation (TAVI) system™. The Company will sponsor this CE Mark-enabling pilot study on patients with severe Aortic Stenosis and begin to […]
European Society of Cardiology Heart Failure Journal Publishes New Plasma Volume Heart Failure Study Data from FAST BioMedical
The ESC Heart Failure Journal shares additional results from FAST BioMedical’s EMPAKT CHF clinical study. INDIANAPOLIS (Dec. 10, 2021) — FAST BioMedical (FAST), a privately held late clinical-stage medical technology company, today announces theEuropean Society of Cardiology (ESC) Heart Failure Journal has published additional results from its fourth human […]
Eisenhower Health First in California to Complete Edwards Benchmark™ Program for Transcatheter Aortic Valve Replacement (TAVR)
ONLY HOSPITAL IN COACHELLA VALLEY TO OFFER TAVR RANCHO MIRAGE, Calif., Dec. 16, 2021 /PRNewswire/ — Eisenhower Health is the FIRST hospital in California to be recognized by Edwards Lifesciences for completing its Edwards Benchmark program for the treatment of aortic stenosis in patients undergoing transcatheter aortic valve replacement (TAVR). The standard treatment for aortic […]
Mpirik’s Cardiac Intelligence® Automated Screening Demonstrates 98.6% Accuracy with Moderate and Severe Aortic Stenosis.
MILWAUKEE, Dec. 14, 2021 /PRNewswire/ — Mpirik, an A.I. healthcare technology company that develops automated patient screening models for cardiovascular disease to drive actionable insights, quality and research, has published research in the Annals of Thoracic Surgery about their screening success. The study looked at undertreatment of aortic stenosis, a cardiovascular disease with […]
Windtree Announces U.S. Patent and Trademark Office Issuance of New U.S. Istaroxime Patent
New Patent Provides Intellectual Property Protection Through Late 2039 WARRINGTON, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued […]
Aerovate Therapeutics Announces Initiation of IMPAHCT Phase 2b/Phase 3 Trial of AV-101 In Pulmonary Arterial Hypertension
WALTHAM, Mass., Dec. 15, 2021 (GLOBE NEWSWIRE) — Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary diseases, today announced the initiation of its Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) Phase 2b/Phase 3 trial to evaluate the safety and efficacy […]
BioCardia Establishes New Manufacturing Facility to Enable Its Cell Therapy Product Candidates
Facility Being Built Out to Support CardiAMP Cell Therapy Systems, Allogeneic NK1R+ MSC and Biotherapeutic Delivery Device Manufacturing for Clinical Trials of Multiple Programs and Early Commercial Activities SAN CARLOS, Calif., Dec. 15, 2021 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of […]



