CardioWestTM Total Artificial Heart Wins Approval from FDA

The CardioWestTM Temporary Total Artificial Heart approved by the U.S. Food and Drug Administration.

CardioWestTM Total Artificial Heart Wins Approval from FDA

TUCSON, Ariz. -- The CardioWestTM Temporary Total Artificial Heart today became the only device of its kind to be approved by the U.S. Food and Drug Administration.
"This takes the CardioWest TAH off of the Medicare 'experimental list,'" said University of Arizona cardiothoracic surgeon Jack G. Copeland, MD, who led the study of the device. "It's a huge relief to know that 19 years of work with the device has been officially recognized and that a technology that we believed in has now been released for use by others."

The CardioWestTM is an air-driven (pneumatic) device that is placed in the chest (replacing the ventricles and all four heart valves) and an external console that controls its functions. The "bridge-to-transplant" device is implanted in patients facing imminent death due to failure on both sides of the heart and helps them stay alive until a human donor heart is available.

Compared with other artificial heart systems that have been tested, the CardioWestTM has the shortest blood path and exposure to artificial surfaces, which reduces the risk of infection and clots, and the highest level of cardiac output (amount of blood pumped with each heartbeat).

A nine-year study of the CardioWestTM showed that patients become better candidates for eventual transplantation. The results, published in The New England Journal of Medicine in August, showed that those who received the CardioWestTM had a one-year survival rate of 70 percent, compared with 31 percent for patients in the study who did not receive the artificial heart.

The FDA's approval is a stamp of credibility for "all of the members of our team who have worked hard and believed with me that we could save the lives of some of the sickest heart failure patients and make them better candidates for cardiac transplantation," Dr. Copeland said. A professor of surgery at the UA College of Medicine and a co-director of the UA Sarver Heart Center, Dr. Copeland is a world leader in cardiac transplantation, as well as in the development and use of artificial heart devices.

The CardioWestTM evolved from the Jarvik-7 total artificial heart, which was developed at the University of Utah and implanted for the first time in 1982. In 1985, the FDA approved use of the device as a bridge to transplant at University Medical Center and Dr. Copeland became the first surgeon in the world to use an artificial heart as a successful bridge. In 1991, University Medical Center and MedForte Research Foundation created CardioWest Technologies Inc. and the device's technology was transferred to the new company.

"For UMC, this is a proud moment," Dr. Copeland said. "They supported the idea of this excellent technology and believed it would be beneficial for heart failure patients."

In 2001, UMC turned the technology over to a new company called SynCardiac Systems, Inc. The company was founded by Dr. Copeland; Marvin J. Slepian, MD, a clinical professor of medicine at the UA College of Medicine and a member of the Sarver Heart Center, and now president and chief executive office of SynCardia; and Richard G. Smith, director of UMC's Marshall Foundation Artificial Heart Program.

The centers involved in the study were UMC; Loyola Medical Center, in Chicago; LDS Hospital, in Salt Lake City; Saint Luke's Medical Center, in Milwaukee; and University of Pittsburgh Medical Center. The study was initiated in 1993 and concluded in 2002.

For additional information about SynCardia, please contact Lauren Arnold of Kristina Ebenius at Schwartz Communications, (781) 684-0770.


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(The following is a news release issued today by SynCardia Systems)

FOR IMMEDIATE RELEASE
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SynCardia Systems Announces First-Ever FDA Approval of Total Artificial Heart

CardioWestTM Temporary Total Artificial Heart Serves as a Bridge-to-Transplant for Non-Reversible Heart Failure Patients Awaiting Heart Transplants


Tucson, Ariz.-October 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 CardioWestTM 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 CardioWestTM TAH-t is the first FDA-approved temporary total artificial heart.

The CardioWestTM 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 CardioWestTM 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."

About the CardioWestTM Temporary Total Artificial Heart

The CardioWestTM TAH-t is a pneumatic, biventricular, implantable bridge-to-transplant system for full cardiac replacement, taking the place of the failing heart in patients at imminent risk of death. The device offers full circulatory support, the shortest blood path and exposure to artificial surfaces, and the highest level of cardiac output when compared with other artificial heart systems previously tested. With the CardioWestTM TAH-t, patients become better candidates for eventual transplantation and have post-transplant survival rates equal to that of non-device cardiac recipients.

About SynCardia Systems

Founded in 2001, SynCardia Systems is the developer of biomechanical cardiac replacement and assist devices. Its CardioWestTM Temporary Total Artificial Heart (TAH-t) is designed for severely ill patients with end-stage congestive heart failure. The device serves as an in-hospital bridge-to-transplantation for patients at imminent risk of death. SynCardia Systems is based in Tucson, Arizona and is on the Web at http://www.syncardia.com.

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