Press Release:

TUCSON, Ariz. – March 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’s (FDA) Circulatory Systems Devices Panel met yesterday and recommended that the CardioWest™ temporary Total Artificial Heart (TAH-t) be approved, with conditions, by the FDA.

The panel recommendation was on SynCardia’s pre-market approval (PMA) application for CardioWest™ TAH-t’s usage as a bridge-to-transplantation in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure. The panel’s recommendation came with conditions, namely post-market surveillance of patients, surgeries needing to occur at heart transplant centers, and more detail on the labeling.

“The panel’s positive recommendation means that the CardioWest™ TAH-t is on course to become the world’s first FDA-approved total artificial heart, making it a viable option for the many seriously ill patients with non-reversible heart failure who are awaiting heart transplants,” said Dr. Marvin Slepian, president and CEO, SynCardia. “The CardioWest™ TAH-t rounds out the therapeutic toolbox for cardiac surgeons and cardiologists, filling a gap not previously met. This is a success story on many levels–for patients and the SynCardia team that has worked on this for years. In addition, this is an important milestone 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