Home » Abiomed Gets European OK for Circulatory Support Driver
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.
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