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 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