Press Release:

TUCSON, Ariz. – June 21, 2005 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and mechanical circulatory support devices, announced today use of its CardioWest™ temporary Total Artificial Heart (TAH-t) as a permanent cardiac replacement-also called destination therapy-in two patients in Europe. Over the past few weeks, the Heart Center NRW at Bad Oeyenhausen, Germany, under the leadership of Drs. El Banyosy and Reiner Korfer, and the German Heart Institute in Berlin, under the leadership of Drs. Michael Jurmann and Roland Hetzer, have successfully implanted the devices.

The decisions to use the CardioWest™  TAH-t were physician-initiated, not sponsored by SynCardia, and met individual medical center ethics committee approval. The CardioWest™  TAH-t was chosen for these patients as they had irreversible bi-ventricular heart failure and were ineligible for transplants. Both patients have successfully recovered on the CardioWest™  TAH-t and have been discharged home on portable drivers adapted to power the CardioWest™ TAH-t.

“We are encouraged by this physician-initiated effort into the domain of destination therapy,” said Dr. Marvin J. Slepian, president and CEO, SynCardia Systems. “While currently approved by the FDA in the United States as a bridge-to-transplantation device, the CardioWest™  TAH-t has, by engineering design, the intrinsic potential to serve as a long-term cardiac replacement. In the future we hope to launch a formal company-sponsored destination therapy trial, with the approval of regulatory agencies, both outside of and within the United States.”

The CardioWest™  TAH-t is the first FDA-approved temporary total artificial heart. It is currently indicated for use as a bridge-to-transplant in cardiac transplant-eligible candidates at risk of imminent death from non-reversible bi-ventricular failure. The device is being used in heart transplant centers in the United States and Europe. Additional clinical studies are also being conducted with new, smaller drivers.

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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