Press Release:

TUCSON, Ariz. – Sept. 7, 2005 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and mechanical circulatory support devices, announced today the company is recognizing the milestone event of utilization of a total artificial heart for successful bridge-to-heart transplantation.

The pioneering step of utilization of a total artificial heart to bridge a dying patient to heart transplantation was first performed successfully utilizing a precursor-design of the present total artificial heart by SynCardia co-founder Dr. Jack Copeland and his team at University Medical Center in Tucson, AZ. on Sept. 7, 1985.

Based on this concept, SynCardia developed the first FDA-approved and CE-marked temporary total artificial heart, known as the CardioWest™ temporary Total Artificial Heart (TAH-t).

In October 2004, the US Food and Drug Administration approved the CardioWest™ TAH-t 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.

“We are thrilled to have reached this landmark point and celebrate the fact we were able to see through to fruition the development of this first-of-its kind, life-saving artificial heart technology,” said Dr. Marvin J.Slepian, Chairman and Chief Scientific Officer, SynCardia Systems. “We are excited to continue to move forward with the next phase of development, which is utilization of the TAH-t for permanent cardiac replacement or ‘destination therapy.’”

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. To date, there have been over 570 implants of total artificial hearts of the SynCardia CardioWest™ TAH-t design.

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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