Press Release:

TUCSON, Ariz. – Aug. 25, 2004 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and assist devices, today announced that the August 26 issue of the New England Journal of Medicine features the results of the multi-center study of the company’s CardioWest™ temporary Total Artificial Heart (TAH-t).

The purpose of the study was to establish the safety and efficacy of the CardioWest™ TAH-t in transplant-eligible patients at risk of imminent death from irreversible biventricular cardiac failure. Results conclusively showed that the CardioWest™ TAH-t reduced mortality and afforded clinical stabilization for these patients.

The study was a prospective, investigator-initiated trial of the CardioWest™ TAH-t, conducted under an FDA Investigational Device Exemption (IDE). Of the 130 patients involved in the study 81 patients were implanted with the device. 35 were historical controls and 14 were out-of-protocol compassionate use patients who did not meet inclusion and exclusion criteria. The rate of survival to transplant was 79 percent for patients implanted with the CardioWest™ TAH-t. Of the 35 control patients, 45.7 percent survived to transplant. Overall one year survival rate for implanted patients was 70.4 percent compared to 31.4 percent for controls. One and five year survival rates for total artificial heart bridged patients post transplant were 85.9 and 65.2 percent, respectively.

The centers involved in the study were the University Medical Center, Tucson, Arizona; Loyola Medical Center, Chicago, Illinois; LDS Hospital, Salt Lake City, Utah; Saint Luke’s Medical Center, Milwaukee, Wisconsin; and University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. The study was initiated in 1993 and concluded in 2002.

“This study represents the culmination of nine years of research and data, and we were thrilled that the device was recommended for approval, with conditions, by the FDA Circulatory Systems Devices Advisory Panel in March,” said Dr. Marvin J. Slepian, president and CEO, SynCardia. “This is a significant milestone not only for the company and for patients and their families, but also a huge step in medical history.”

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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