SynCardia nets FDA nod for Freedom Driver investigational study
SynCardia Systems, a manufacturer of temporary artificial hearts, has received conditional approval from the FDA to conduct an investigational device exemption (IDE) clinical study of the Freedom driver system, a portable driver designed to power its Total Artificial Heart.
The IDE clinical study is designed to demonstrate that stable Total Artificial Heart patients in the U.S. can manage their portable driver outside the hospital environment, including at home, in their communities and at step-down facilities.
With the Total Artificial Heart as a bridge-to-transplant device, patients are confined to the hospital while they await a heart transplant, according to the company, because the FDA-approved driver for powering the Total Artificial Heart is the 418-lb hospital driver.
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. Tucson, Ariz.-based SynCardia said its Freedom driver weighs 13.5 lbs including two onboard lithium-ion batteries and a power adaptor, and is designed to be carried by the patient in a backpack or shoulder bag.
The IDE clinical study is designed to demonstrate that stable Total Artificial Heart patients in the U.S. can manage their portable driver outside the hospital environment, including at home, in their communities and at step-down facilities.
With the Total Artificial Heart as a bridge-to-transplant device, patients are confined to the hospital while they await a heart transplant, according to the company, because the FDA-approved driver for powering the Total Artificial Heart is the 418-lb hospital driver.
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. Tucson, Ariz.-based SynCardia said its Freedom driver weighs 13.5 lbs including two onboard lithium-ion batteries and a power adaptor, and is designed to be carried by the patient in a backpack or shoulder bag.