Press Release:

TUCSON, Ariz. – Oct. 18, 2004 – SynCardia Systems, a privately held developer of biomechanical cardiac replacement and assist devices, announced today that the U.S. Food and Drug Administration (FDA) approved its CardioWest™ temporary Total Artificial Heart (TAH-t) as a bridge-to-transplantation in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure. The CardioWest™ TAH-t is the first FDA-approved temporary total artificial heart.

The CardioWest™ TAH-t completely replaces the patient’s diseased heart and immediately restores normal blood pressure and cardiac output, facilitating recovery of end-organ function, such as the kidney and liver. As a result, patients become better candidates for transplantation.

“The FDA’s approval of the first temporary total artificial heart represents a significant milestone in medical history. With the CardioWest™ TAH-t, we will be able to save the lives of many critically ill patients who are in need of or who are awaiting heart transplants. The CardioWest™ TAH-t fills an unmet medical need, and we are thrilled to offer this device to cardiac surgeons and cardiologists at heart transplant centers nationwide,” said Dr. Marvin J. Slepian, president and CEO, SynCardia Systems.

“Over nine years ago, we began collecting research and data on the efficacy of the CardioWest™ temporary Total Artificial Heart and today’s approval from the FDA represents the culmination of our efforts,” said Dr. Jack G. Copeland, Chief, Section of Cardiovascular and Thoracic Surgery, University of Arizona Sarver Heart Center. “This is a tremendous day not only for SynCardia but for all people and their families affected by non-reversible biventricular failure.”

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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