Press Release:

TUCSON, Ariz. – Aug. 1, 2005 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and mechanical circulatory support devices, announced today implantation of its CardioWest™ temporary Total Artificial Heart (TAH-t) in a patient at The Cleveland Clinic. The Cleveland Clinic is the first “new” center, beyond the institutions that previously participated in the recently reported pivotal U.S. multi-center trial, to adopt this technology. The TAH-t received FDA approval allowing commercial distribution in late 2004.

“The CardioWest™ TAH-t is the only FDA approved device capable of providing full circulatory restoration in morbidly ill patients with irreversible bi-ventricular failure, ultimately bridging them to transplantation when a donor heart becomes available,” said Dr. Marvin J. Slepian, President and CEO, SynCardia Systems. “We’re pleased that an esteemed institution like The Cleveland Clinic has adopted the TAH-t and we look forward to working closely with them on future studies examining the possible extension of this technology allowing for post-recovery discharge of patients and ultimately for use in destination therapy.”

“This technology provides physicians with a device that is specifically designed for patients with severe biventricular failure,” said Dr. Nicholas Smedira, Director of Transplantation and Mechanical Circulatory Devices at The Cleveland Clinic. “The CardioWest™ TAH-t restores normal hemodynamics and organ perfusion in critically ill end-stage patients with end-stage congestive heart failure, thereby enabling patients to become better candidates for eventual transplantation.”

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.

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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