The Latest Cardiac and Vascular News
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 […]
Offers cardiac surgeons with a best-in-class biomaterial indicated for pericardial repair and reconstruction, and epicardial support and repair WESTON, Mass., Jan. 5, 2022 /PRNewswire/ — Helios Cardio Inc. announces the Food and Drug Administration (FDA) 510(k) clearance for commercial distribution of CardiaMend™ Pericardial and Epicardial Reconstruction Matrix. CardiaMend™ Pericardial and Epicardial Reconstruction […]
Amended study design provides immediate access and clinical benefits for all patients and becomes the first global IDE study for PA pressure-guided heart failure management LISLE, Ill., Jan. 5, 2022 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the […]
