FDA panel recommends approving first-ever heart assist device for sale in US.

The government is on the verge of approving the first-ever artificial heart device for sale in the US.

A Food and Drug Administration (FDA) advisory has given the green light for the use of SynCardia System's, Tucson, AZ artificial heart to be used as a bridge to transplantation in

By a vote of 10-1 with one abstention, the FDA's Circulatory System Devices Advisory Panel recommended approval of the CardioWest Total Artificial Heart (TAH) which was developed by the University Medical Center of the University of Arizona in Tucson.

The panel recommended that the CardioWest heart, which has been tested at 5 centers across the nation, be approved for use in the approximately 120 US hospitals that perform heart transplants.

The device, which is a modified version of the Jarvik heart, the first artificial heart ever implanted in a human, in December 1982, has been used to save the lives of more than 200 patients in the US and Europe, according to the Arizona Daily Star. Almost 80% of those patients survived long enough to get a life saving heart transplant.

The advisory panel recommended the FDA limit the use of the device to transplant centers, and recommended that SynCardia be required to chart the progress of the patients using the device for the first year after approval.

The FDA is not bound to follow the advisory panel's recommendation but usually follows them. Until the approval is given, which is expected in the next few months, the artificial heart will still be considered an experimental device.

Patients who use the device are not allowed to leave the hospital. The CardioWest heart is attached to the upper chambers of the patient's heart after the ventricles in the lower chamber, which pump the blood through the body, have been removed. Air hoses run from the artificial device through an incision in the patient's abdomen to a washing-machine-sized console.

Researchers are working on a "luggable" version of the CardioWest heart that would allow the patient to leave the hospital with the device in place, driven by a portable air pump that could be carried in a purse or backpack, the Star reported.