The Latest Cardiac and Vascular News
SILVER SPRING, Md., March 21, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. […]
LAKE OSWEGO, Ore., March 14, 2019 /PRNewswire/ — BIOTRONIK today announced FDA approval of the Acticor and Rivacor high-voltage cardiac rhythm management (CRM) device families for treatment of patients with cardiac arrhythmias. The six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor […]
SILVER SPRING, Md., March 14, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium that can cause […]
HOUSTON–(BUSINESS WIRE)–Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird Bleed Monitoring System. According to a recent […]
DUBLIN – February 26, 2019 – Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) approval of its Resolute Drug-Eluting Stent (DES) platform (including the Resolute Onyx(TM) and Resolute Integrity(TM) DES) for the treatment of patients with coronary artery disease who have de novo chronic total occlusion (CTO), a complex […]
WESTMINSTER, Colo., Feb. 20, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval to begin an Early Feasibility Study of the Tria surgical aortic heart valve for the treatment of aortic valve disease. Using breakthrough LifePolymer™ – a proprietary advanced biopolymer material – and […]
WALTHAM, Mass.–(BUSINESS WIRE)–Corindus Vascular Robotics, Inc. (“Corindus” or the “Company”) (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today it is seeking premarket clearance from the U.S. Food and Drug Administration (FDA) to use the CorPath GRX System in neurovascular intervention. CorPath GRX, the second generation robotic platform, received FDA clearance for percutaneous […]
DUBLIN – February 7, 2019 – Medtronic plc (NYSE:MDT) announced today that it has received U.S. Food and Drug Administration (FDA) approval on an expanded indication for its Pipeline(TM) Flex embolization device.1 Previously indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid […]
WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced that it received premarket approval (PMA) from the U.S. Food and Drug Administration for the MANTA™ Vascular Closure Device – the first commercially available biomechanical vascular closure device designed specifically […]
