FDA approves partial artificial heart

Oct 18 2004

The U.S Food and Drug Administration (FDA) has approved a partial artificial heart intended to keep people alive in the hospital while they are awaiting a heart transplant.

The product is a pulsating bi-ventricular device that is implanted into the chest to replace the patient's left and right ventricles (the bottom half of the heart). The implanted device is sewn to the patient's remaining atria (the top half of the heart). Hospitalized patients are connected by tubes from the heart through their chest wall to a large power-generating console, which operates and monitors the device.

The heart is manufactured by Syncardia Systems Inc., of Tucson, Ariz. It is intended as a "bridge to transplant" for people waiting for a heart transplant who do not respond to other treatments and are at risk of imminent death from non-reversible bi-ventricular failure, i.e. people with both left and right side heart failure, and who are eligible for a heart transplant.

FDA approved the Syncardia device based on a review of clinical studies of safety and effectiveness conducted by the firm and on the recommendation of an outside panel of experts convened by FDA to review the device.

The firm studied use of the artificial heart in 81 transplant-eligible patients with severe bi-ventricular heart failure at five medical centers in the United States. In the studies, 79 percent of patients implanted with the heart remained alive long enough to receive a donor heart (an average of 79 days), demonstrating that the artificial heart could successfully serve as a bridge to transplant.

Complications included infection (72% of patients), bleeding (42%), neurological event such as major or minor stroke (25%) and device malfunctions (18%). Seventeen patients in the study died before a donor heart became available.

About 4,000 patients in the United States await heart transplants annually. Only about 2,200 donor hearts typically become available. About 100 of the 4,000 patients awaiting transplants have non-reversible bi-ventricular failure and could be candidates for the new artificial heart.

FDA is requiring the firm to conduct a post-approval study to monitor the device's performance in commercial use.

From SynCardia Systems

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 CardioWest™ 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 CardioWest™ TAH-t is the first FDA-approved temporary total artificial heart.

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.

"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 CardioWest 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."

The CardioWest&trade 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 CardioWest™ TAH-t, patients become better candidates for eventual transplantation and have post-transplant survival rates equal to that of non-device cardiac recipients.