Abiomed Gets European OK for Circulatory Support Driver

Massachusetts-based Abiomed has received CE Marking approval for its portable circulatory support driver for its AB5000 ventricular assist device (VAD).

The 18-pound driver provides patients requiring VAD support a greater degree of mobility and improved quality of life during treatment, Abiomed said.

The device is used as a bridge to recovery and a bridge to transplant.

The company submitted an investigational device exemption to the FDA in January to conduct a discharge study. It is working to resolve questions the agency raised.