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 […]
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 […]
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 […]
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 […]
– 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 […]
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 […]
– 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. […]
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 […]
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 […]
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. […]
