The Latest Cardiac and Vascular News
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 […]
SEOUL, South Korea and BETHESDA, Md., Dec. 21, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of a very large subgroup of patients with congenital single ventricle […]
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 […]
Indication for Pre-Surgical Vein Dilation Use to Promote AV Fistula Creation LAS VEGAS–(BUSINESS WIRE)–Fist Assist Devices, LLC, an innovative medical device company focused on vein dilation to facilitate the Chronic Kidney Disease (CKD) patient’s journey through End-Stage Renal Disease (ESRD), announced today that it received “Breakthrough Device” designation from the […]
Algorithm reduces the volume of false positives from Medtronic implantable loop recorders by nearly 80% to boost medical staff productivity by focusing on meaningful cardiac arrhythmia events CAMBRIDGE, Mass., Dec. 16, 2021 /PRNewswire/ — Implicity, a leader in remote patient monitoring and cardiac data management solutions, today announced FDA clearance for a novel […]
World’s Lowest Profile Drug-Eluting Stent Systems with the Lowest Rate of 1 Year Reintervention Reported in a U.S. Pivotal Study Now Approved for Use in U.S. Patients NEW PROVIDENCE, N.J.–(BUSINESS WIRE)–Svelte Medical Systems received U.S. Food and Drug Administration (FDA) approval to commercialize the SLENDER IDS® fixed-wire and DIRECT RX® rapid-exchange drug-eluting […]
Advanced innovations leverage HeartFlow’s core AI technology and are critical additions to HeartFlow’s product portfolio for delivering complete cardiac care REDWOOD CITY, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced it has submitted a 510k premarket application to the U.S. Food […]
