Press Release:

The Companion Driver System has the CE Mark for use in Europe. It is not FDA-approved for use in the U.S.

TUCSON, Ariz. – Oct. 15, 2009 – On Oct. 15, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, 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 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 docked into the Hospital Cart for the OR/ICU. It is redocked into a portable caddy for stable Total Artificial Heart 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.

Medical professionals can view Companion Driver training units at the following upcoming European medical meetings:

• EACTS, Vienna, Austria, Oct. 17–21
• Berlin Symposium: Mechanical Circulatory Support, Berlin, Germany, Nov. 6–8
• EUMS, Paris, France, Dec. 2-5

CE Mark Approval: Design Examination Certificate (PDF) & Full Quality Assurance Certificate (PDF)

###

About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 patient years of life on the device. 

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News

Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660