EU approves SynCardias companion system for Total Artificial Heart

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SynCardia Systems, manufacturer of the temporary CardioWest Total Artificial Heart, reported that its new Companion Driver system has received CE Mark approval to power the Total Artificial Heart in Europe.

Proven Process Medical Devices, an original equipment manufacturer, has committed to producing 85 Companion Drivers by the year end, in addition to hospital carts for the operating room/ICU and portable caddies for stable patients, according to the Tucson, Ariz.-based company.

SynCardia said its Companion Driver also is designed to power its future family of pulsatile devices, including the 50cc Total Artificial Heart and the 10cc, 30cc and 60cc ventricular assist devices.

In October, SynCardia submitted a premarket approval supplement to the FDA for approval of the Companion Driver in the U.S.