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 smaller 50cc Total Artificial Heart currently under development.

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 the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 950 implants of the Total Artificial Heart, accounting for more than 230 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
Like SynCardia on Facebook
Follow SynCardia on Twitter – @SynCardia
Connect with SynCardia on LinkedIn

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