Press Release:

From R to L: Prof. Jean-Philippe Verhoye, Dr. Erwan Flecher, Dr. Christian Felix and Pierre Simon from Rennes University Hospital with the new Companion Driver System for powering the SynCardia Total Artificial Heart in Europe. The Companion received CE Mark approval on Oct. 13.

TUCSON, Ariz. – Oct. 28, 2009 – On Oct. 26 & 27, the surgical team from Rennes University Hospital, led by Dr. Erwan Flecher and Prof. Jean-Philippe Verhoye, completed the first phase of certification training for the SynCardia temporary CardioWest™ Total Artificial Heart in Paris. The team trained exclusively with the new Companion Driver System, which received the CE Mark to power the Total Artificial Heart in Europe on Oct. 13.

“We perform anywhere from 1,200 to 1,400 open heart surgeries annually,” said Dr. Flecher, who was first introduced to the Total Artificial Heart as a resident at La Pitié in 1999. “It is critical for us to have this life-saving technology to save our sickest patients. We look forward to Phase 3 of certification training, our proctored first implant of the Total Artificial Heart using the new Companion Driver System.”

The Companion Driver System represents the next generation in pneumatic driver technology. The user-friendly touch screen display provides access to all driver functions and modes, no keyboard required. To make it simpler for hospitals and patients, the Companion Driver is serviced by replacement. No on-site repair, service or inventory of parts is required. Drivers are delivered and returned via express delivery service.

Rennes University Hospital has six cardiac care operating rooms. In 2007, the hospital performed 22 heart transplants. Rennes University Hospital is the 45th hospital in the world and the 26th in Europe to complete the first phase of certification training to become a SynCardia Certified Center.

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