SynCardia plans to test its artificial heart as a permanent implant rather than a placeholder for donor transplants in 19 patients.
The Arizona company said it won the FDA’s approval to move ahead with the clinical study of its temporary Total Artificial Heart as a permanent transplant option. This is a big advance forward for SynCardia, which has FDA approval only to use the device as a bridge to transplant. It is designed for terminal patients with end-stage biventricular heart failure – in which 2 ventricles of the heart can’t pump enough blood.
Qualifying patients must be ineligible for a donor heart transplant. Beyond the Total Artificial Heart implant, they’ll also get SynCardia’s FDA-approved battery-powered Freedom portable driver, which powers the heart and is designed to help improve patient mobility and let them leave the hospital the company said. Patients can carry it in a shoulder bag, backpack or cart.
SynCardia president & CEO Michael Garippa said the study will generate data on how effectively the Total Artificial Heart can help patients recover from heart failure and live a close-to-normal lifestyle, something this group has not been able to contemplate before.
“This is an important step for SynCardia to advance the use of the Total Artificial Heart to a new group of patients who are not currently eligible for a donor heart,” Garippa said in prepared remarks.
SynCardia said a patient lived nearly four years with a Total Artificial Heart before finally getting a successful donor heart transplant.
A little over a year ago, SynCardia raised $14 million for development of a smaller version of its total artificial heart as a bridge-to-transplant therapy.