The Latest Cardiac and Vascular News
– 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 […]
December 22, 2021 Philips IVC Filter Removal Laser Sheath – CavaClear – is intended to safely ablate tissue to remove embedded IVC filters CavaClear is a first-in-class FDA-cleared solution for advanced IVC filter removal It is estimated that in the United States more than one million patients with IVC filters […]
– With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction(1) – Leqvio provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain people with atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statin […]
SILVER SPRING, Md., Dec. 21, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The device is designed for patients who have an IVC filter, a small cage-like device inserted into the largest vein in […]
XARELTO® is available as both an oral tablet and oral suspension formulation for use in appropriate children less than 18 years of age Convenient oral suspension formulation advances standard of care for children; alleviates administration challenges found with injectable alternatives XARELTO® now has 11 indications, the most of any direct […]
