Press Release:

CardioWest patient Mr. Potiron on the CE approved portable driver with Prof. Daniel Duveau, medical director for University Hospital of Nantes. Mr. Potiron was able to go outside the hospital for the first time in more than a year thanks to the portable driver.

TUCSON, Ariz. – Nov. 20, 2008 – On Oct. 22, CardioWest temporary Total Artificial Heart patient Mr. Potiron shed 430 lbs when he was switched to the 20-lb CE approved portable driver after nearly a year of support on the 450-lb hospital driver “Big Blue” at University Hospital of Nantes.

“I wouldn’t be here today if it weren’t for the CardioWest artificial heart,” said Mr. Potiron. “I am very grateful for my second chance at life. However, it has been difficult for me over the past year because I’ve been pushing around an extra 450 lbs. Now with the portable driver, I can go for a walk in the park, buy a newspaper and get a drink at the cafeteria.”

“In some European countries, artificial heart patients can wait up to two years for a matching donor heart,” said Prof. Daniel Duveau, the medical director for University Hospital of Nantes and a CardioWest certified proctor. “Even though Mr. Potiron is stable and doing well, the 450-lb hospital driver that powered his artificial heart during surgery and recovery limited his mobility. Now that he is using a portable driver, his quality of life has improved dramatically.”

“Big Blue” is a 450-lb hospital driver that powers the CardioWest artificial heart during surgery and recovery.

“We have waited for a long time to put one of our patients on the portable driver because it is in limited supply,” said Prof. Duveau. “If we had a back-up portable driver for Mr. Potiron, we would be able to discharge him to wait at home for a matching donor heart. We eagerly await the arrival of the new Companion Driver System so that more of our artificial heart patients can enjoy a near-normal quality of life at home. Many of these patients can shop, travel, visit family and participate in other normal activities.”

In January 2009, SynCardia will apply to the FDA to conduct an IDE clinical study of the Companion Driver System in the U.S. and apply for CE approval in Europe. The Companion Driver is designed for use in both the hospital and at home. SynCardia projects a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the 24 months following regulatory approvals.

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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