Press Release:

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 new Freedom driver for powering SynCardia’s Total Artificial Heart.

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)

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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 950 implants of the Total Artificial Heart, accounting for more than 230 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660