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 the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 950 implants of the Total Artificial Heart, accounting for more than 230 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660