Freedom Driver Earns Medical Device CE Mark

The Freedom driver system, manufactured by SynCardia, maker of the temporary CardioWest Total Artificial Heart, has received the CE Mark to power the Total Artificial Heart in Europe.

“The new Freedom driver is the first wearable portable driver for powering the Total Artificial Heart,” says Rodger Ford, president and CEO of SynCardia. “It will allow stable European Total Artificial Heart patients to enjoy a quality lifestyle at home and in their communities while they wait for a matching donor heart.”

SynCardia hospital drivers support patients from Total Artificial Heart implant until their condition stabilizes. Once stable, European patients will be switched to the Freedom driver and discharged from the hospital to wait for their matching donor heart at home.

The Freedom driver weighs 13.5 lb including two onboard lithium ion batteries and a power adaptor. It can be conveniently carried by the patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is 60% lighter than SynCardia’s older CE approved proof of concept portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy.

The Freedom driver uses a dark cockpit design philosophy for simple and easy operation. Similar to an airplane cockpit, the system only flashes a light or sounds an alarm when something requires the user’s attention.

To make maintenance easier for hospitals, the Freedom driver is serviced by replacement via express delivery. No onsite repair or inventory of parts is required by the hospital.

SynCardia has also submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom driver in the U.S.