After review by the British Standards Institution (BSI), the European Union has granted SynCardia (Tucson, Arizona) approval to market the Companion Driver System to power the firm’s temporary CardioWest™ Total Artificial Heart. The unit provides the ability to discharge certain patients home while they are waiting for a transplant.
“The new fleet of Companion Drivers will supplement the 36 ‘Big Blue’ hospital drivers currently in use, more than tripling implant capacity by year-end,” said Rodger Ford, SynCardia CEO and President. “The Companion Driver will also supply the drivers we need to train the backlog of transplant centers waiting to become certified on the Total Artificial Heart.”
Proven Process Medical Devices, one of the largest medical Original Equipment Manufacturers in the world, has committed to producing 85 Companion Drivers by year-end, in addition to Hospital Carts for the OR/ICU and portable caddies for stable patients.
The Companion Driver is also designed to power SynCardia’s future family of pulsatile devices, including the 50cc Total Artificial Heart and the 10cc, 30cc and 60cc ventricular assist devices (VADs).
In October, SynCardia submitted a Pre-Market Approval Supplement to the FDA for approval of the Companion Driver in the U.S.