SynCardia Gets FDA Nod to Study Temporary Artificial Heart as Total Replacement

SynCardia said Tuesday that the FDA approved its request to study the effectiveness of its Total Artificial Heart as a permanent replacement in 19 patients. The device currently is approved as a bridge until a patient receives a permanent donor heart.

The Total Artificial Heart is designed for patients with end-stage biventricular heart failure, in which the two ventricles of the heart can’t pump enough blood for the patient to survive.

The device is powered by the Freedom portable driver, which allows for increased mobility and activity. Patients can carry the battery-powered driver in a knapsack or cart when away from the hospital, the Tucson, Ariz., company says. 

President and CEO Michael Garippa says the study will generate data on how effectively the Total Artificial Heart can help patients recover from heart failure and live a near-normal life. “This is an important step for SynCardia to advance the use of the Total Artificial Heart to a new group of patients,” he adds.

SynCardia was notified of the investigational device exemption in December. — Kellen Owings