Portable Artificial Heart Driver Helps Patients Stay Mobile

The Freedom driver system is a portable driver designed to power the SynCardia (Tucson, AZ, USA) CardioWest Total Artificial Heart, for use at their home, in their communities, and at step-down facilities. The Freedom driver weighs six kilograms, including two onboard lithium ion batteries and a power adaptor. It can be conveniently carried by the patient in a proprietary backpack or shoulder bag. The Freedom driver uses a "dark cockpit" design, meaning the driver only flashes a light and sounds an alarm when something requires the user's attention. No onsite repair or inventory of parts is required by the hospital, and service for the driver will only be by replacement via express delivery.

The Freedom driver system has received the European Community (CE marking) approval, and has concomitantly received conditional approval from the U.S. Food & Drug Administration (FDA) to conduct an investigational device exemption (IDE) clinical study of the system. The trial is expected to enroll 60 patients and will follow them until transplant, 90 days after discharge, or death.

"The new Freedom driver is the first wearable portable driver for powering the Total Artificial Heart,” said 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.”

"While waiting for a transplant, patients can stay in the hospital for several months and in some rare cases, more than a year,” said Stephen Clayson, M.D., of the Utah Artificial Heart Program at Intermountain Medical Center (Murray, UT, USA). "We are pleased to initiate the IDE clinical study and evaluate the use of the Freedom driver to power the Total Artificial Heart. If the IDE clinical study of the Freedom driver is successful, patients will be able to sleep in their own bed, spend time with their families, and be more self-sufficient.”

Related Links:
SynCardia
Intermountain Medical Center