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SynCardia Systems, Inc.

Press Release:

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

SynCardia’s “Big Blue” hospital driver supports patients from implant of the Total Artificial Heart until their condition stabilizes. Once stable, European patients will be switched to the new, wearable Freedom driver system to wait at home for a matching donor heart SynCardia’s “Big Blue” hospital driver supports patients from implant of the Total Artificial Heart until their condition stabilizes. Once stable, European patients will be switched to the new, wearable Freedom driver system to wait at home 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.

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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