Abiomed Inc. won FDA PMA approval for its Impella CP heart pump with Smartassist and optical sensor, an update to its cardiac recovery portfolio. Clinical information gathered in testing of more than 60 technical specifications and data on engineering of the Impella Controller at two U.S. hospitals and among 38 patients led to the clearance. A temporary ventricular support device, Impella CP with Smartassist, will be marketed to select hospitals that meet designated heart recovery practices across the next fiscal year. Read More
