Press Release:

Dr. Stephen Clayson, Associate Surgical Director for the Utah Artificial Heart Program at Intermountain Medical Center

SALT LAKE CITY – Jan. 3, 2008 – On Jan. 3, Intermountain Medical Center (formerly LDS hospital) will complete the second phase of certification training for the CardioWest™ temporary Total Artificial Heart (TAH-t), bringing the artificial heart one step closer to returning to Utah. The third and final phase will be the proctored first implant of the artificial heart.

“Utah’s artificial heart program here at Intermountain Medical Center will be one of only a handful of centers across the country to discharge patients with a total artificial heart,” explained surgeon Stephen Clayson, M.D.

In the first half of 2008, SynCardia plans to submit an application to the FDA for an IDE clinical study of a new driver system designed for use in both the hospital and for discharge. If the study is approved, it will be the first IDE clinical study of a discharge driver for the CardioWest artificial heart in the U.S.

“U.S. artificial heart patients are currently confined to the hospital while they wait for their donor hearts for transplant,” said Rodger Ford, CEO and president of TAH-t manufacturer SynCardia Systems, Inc. “Since 2006, stable TAH-t patients in Europe have been able to recover at home thanks to the CE approved portable driver. Today, there are three times more artificial hearts being implanted in Europe because of the portable driver: It improves the patients’ quality of life and virtually eliminates in-hospital costs while these patients wait for their donor hearts at home.”

In the 1990s, LDS Hospital was one of five hospitals to participate in the 10-year clinical study of the CardioWest artificial heart. In the study, 79 percent of patients receiving the TAH-t survived to transplant (New England Journal of Medicine 2004; 351: 859-867). This is the highest survival rate for any approved heart device in the world. The TAH-t also has the highest cardiac output of any approved device, pumping up to 9.5L/min.

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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 1,000 implants of the Total Artificial Heart, accounting for more than 250 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