The Latest Cardiac and Vascular News
Expanding patient base and potential of Imara’s small molecule oral inhibitor of phosphodiesterase-9 (PDE9) alongside hemoglobin disorders Phase 2 trial aims to select HFpEF patients with enriched PDE9 expression for targeted approach to a heterogeneous disease Study initiation planned for second quarter of 2022 BOSTON, Jan. 25, 2022 (GLOBE NEWSWIRE) […]
WILMINGTON, Del., January 24, 2022 – Eplontersen has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of transthyretin-mediated amyloidosis, a systemic, progressive and fatal condition. Eplontersen, formerly known as IONIS-TTR-LRx, is a ligand-conjugated antisense (LICA) investigational medicine currently in […]
Bloomington, Ind. — Cook Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI). “CLTI is a debilitating disease of growing prevalence around […]
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today, along with OrbusNeich Medical Company Ltd (OrbusNeich®), announced FDA PMA approval of OrbusNeich’s Scoreflex® NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter […]
– External device uses heart sound and AI to deliver rapid cardiac function assessments via tablet to expand hemodynamic evaluation beyond the Cath lab – LOS ANGELES–(BUSINESS WIRE)–Sensydia, an innovator in rapid, non-invasive measurement of critical cardiac function, today announced that its Cardiac Performance System (CPSTM) has been granted Breakthrough Device Designation by the […]
Live Case will be Broadcasted Today at 11:00am ET TEL AVIV, Israel, Jan. 18, 2022 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for prevention of stroke caused by Carotid Artery Disease (CAD), today announced that a live case demonstration featuring CGuard™ […]
– EnSite™ X EP System with EnSite Omnipolar Technology (OT) provides a 360-degree view of the heart, regardless of catheter orientation, for cardiac mapping without compromise ABBOTT PARK, Ill., Jan. 12, 2022 /PRNewswire/ — Abbott (NYSE: ABT) today announced it has received clearance from the U.S. Food and Drug Administration for the EnSite™ X EP System […]
Commencement of regulatory pathway for U.S. market approval OXFORD, England, Jan. 11, 2022 (GLOBE NEWSWIRE) — GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces the filing of its Pre-Submission for Cardio inCode-SCORE with the Food and Drug Administration (FDA). Cardio inCode-SCORE is an in-vitro […]
DANVERS, Mass.–(BUSINESS WIRE)–Regulators in three countries have granted approvals to Impella surgical products, as Abiomed (NASDAQ: ABMD) continues to execute its strategy for sustainable growth with new products, new indications and new geographies. In the United States, the Food and Drug Administration (FDA) has granted an Early Feasibility Study (EFS) Investigational Device […]
Evkeeza is a first-in-class medicine approved by the U.S. Food and Drug Administration (FDA) and European Commission (EC) to treat an ultra-rare inherited form of high cholesterol TARRYTOWN, N.Y. and NOVATO, Calif., Jan. 7, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Ultragenyx Pharmaceutical Inc. today announced a license and collaboration agreement for Ultragenyx to […]
