The FDA Circulatory System Devices Panel has voted to retain Class III status for the temporary...

|By:, SA News Editor

The FDA Circulatory System Devices Panel has voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Abiomed's (ABMD) Impella 2.5. The retention of Class III status means that ABMD may now be required to file a pre-market approval application for the device, forcing the company to initiate additional clinical trials.