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 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