Freedom® Driver System Receives CE Mark
to Power SynCardia’s Total Artificial Heart in Europe
1st Wearable Portable Driver Allows Stable European Patients
to Enjoy Quality Lifestyle at Home While They Wait for a Matching Donor Heart
TUCSON, Ariz. – Mar. 4, 2010 – On March 4, SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced that its new Freedom® driver system 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,” 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.”
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 lbs 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.
CE Mark: Design Examination Certificate (PDF)
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,350 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by 190 patients, accounting for over 110 years of support.