Press Release:

TUCSON, Ariz. – Oct. 20, 2005 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and mechanical circulatory support devices, today recognizes the one year milestone of the FDA approval of its CardioWest™ temporary Total Artificial Heart (TAH-t). 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.

“This has been a tremendous year for SynCardia, as the CardioWest™ TAH-t continues to be implemented in transplant centers across the country, saving lives of critically ill patients with end-stage congestive heart failure. Several new centers, beyond the institutions that previously participated in the pivotal U.S. multi-center trial, have adopted this critical technology, including The Cleveland Clinic where four patients have been implanted with the device,” said Marvin J. Slepian MD, Founder and Chairman of the Board of SynCardia. “In addition, we continue to make progress in developing smaller, more portable driver technology which powers our device, enabling patients to be increasingly mobile with this system. In Europe, more than 14 patients have been discharged from transplant centers and are at home with our system and a smaller driver, and two patients have had the TAH-t implanted as a permanent cardiac replacement or ‘destination therapy.’”

Dr. Slepian adds, “We continue to make our CardioWest™ TAH-t available to major cardiac transplant centers in the U.S. and abroad and are excited to continue to move forward with the next phase of development.”

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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.

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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660