The Latest Cardiac and Vascular News
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 […]
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 […]
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 […]
IRVINE, Calif., Feb. 19, 2019 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced the Edwards PASCAL transcatheter valve repair system has received CE Mark for the treatment of patients […]
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 […]
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. […]
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 […]
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 – […]
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Today, Cook Medical announced its recent approval from the U.S. FDA for its Zenith Dissection Endovascular System. The system, consisting of a proximal stent-graft component and a distal bare stent component, provides physicians a less invasive alternative to […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ:ABMD) has achieved CE Mark for Impella Connect, the first-of-its kind cloud-based technology that enables secure, real-time, remote viewing of the Impella console for physicians and hospital staff from anywhere with Internet connectivity. European CE Mark adds to […]
