SynCardia’s companion driver system for artificial heart receives CE
20 October 2009
SynCardia Systems, Inc. manufacturer of the SynCardia
temporary CardioWest Total Artificial Heart, has announced that its new
Companion Driver System has received CE Mark approval to power the Total
Artificial Heart in Europe.
“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
Process Medical Devices, a medical original equipment manufacturer, 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.