Arizona Daily Star

Tucson, Arizona | Published: 10.17.2009

Tucson-based SynCardia Systems Inc. said its new Companion Driver System has received CE Mark approval to power the company’s temporary CardioWest Total Artificial Heart in Europe.

Proven Process Medical Devices, a medical equipment manufacturer, has committed to producing 85 Companion Drivers by year’s end, along with equipment carts and portable caddies, SynCardia said.

The new drivers will supplement the 36 ‘Big Blue’ hospital drivers currently in use, more than tripling implant capacity by year-end, SynCardia CEO Rodger Ford said in prepared remarks.

The company said it has submitted an application to the U.S. Food and Drug Administration for approval of the Companion Driver in the U.S.