SynCardia of Tucson, AZ won approval from the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom portable driver that can power the firm’s CardioWest Total Artificial Heart. Approved in Europe earlier this month, the 13.5 lb device can be shoulder worn or carried in a backpack. The trial, to be conducted at University Medical Center at the University of Arizona, Intermountain Medical Center and Virginia Commonwealth University Medical Center, will test whether the Freedom driver is a practical option to discharge stable artificial heart patients to their homes or step-down facilities.
From the announcement:
While the Total Artificial Heart has the highest bridge to transplant rate of all approved mechanical circulatory support devices, the major drawback of existing technology is that patients are confined to the hospital while they await a transplant. This is because the only FDA-approved driver for powering the Total Artificial Heart is the 418-lb hospital driver nicknamed “Big Blue”. Through the IDE, stable Total Artificial Heart patients who meet study criteria will have the option to be discharged from the hospital with the Freedom driver, with the goal of enabling them to resume normal activities at home and in their communities. The Freedom driver weighs only 13.5 lbs including two onboard lithium-ion batteries and a power adaptor. It is designed to be carried by the patient in the Freedom Backpack or Shoulder Bag.
The SynCardia Freedom driver system IDE study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home. The trial is expected to enroll 60 patients and will follow them until transplant, 90 days after discharge or death.
Press release: SynCardia Granted FDA Conditional Approval to Conduct IDE Clinical Study for Freedom™ Driver System
Product page: Freedom driver
Flashback: Syncardia’s Freedom Mobile Artificial Heart Driver Gets CE Mark