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.

###

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 Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 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.

Sign-up to receive the latest news updates from SynCardia
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