Press Release:

The 12-lb Freedom driver is designed to provide stable Artificial Heart patients with a quality “lifestyle” outside the hospital while they wait for a matching donor heart.

TUCSON, Ariz. – April 22, 2009 – On April 22-25, SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, introduced the new 12-lb Freedom® discharge driver at the International Society for Heart and Lung Transplantation (ISHLT) meeting in Paris.

The small, light and “wearable” Freedom driver is designed to provide stable SynCardia Total Artificial Heart patients with a quality “lifestyle” outside the hospital while they wait for a matching donor heart. The Freedom driver is designed to allow patients to live at home, spend time with their family and friends, shop, travel, dine out, attend sporting events, vacation and even return to work.

“The Freedom driver is the next generation in pneumatic driver technology for powering the Total Artificial Heart outside the hospital,” said Rodger Ford, CEO and president of SynCardia. “Our experience discharging stable patients in Europe using our CE approved portable driver has demonstrated that Total Artificial Heart patients can enjoy an active lifestyle at home and in their communities.”

Currently in the U.S., stable Total Artificial Heart patients cannot be discharged. These patients – who are otherwise healthy – must spend weeks, often months trapped in the hospital while they wait for a donor heart. Life for a stable Total Artificial Heart patient confined to the hospital is emotionally, physically and financially draining for them, their family and the hospital.

When the Freedom driver is approved for an FDA / Investigational Device Exemption (IDE) clinical study, stable Total Artificial Heart patients will be discharged from the hospital for the first time in the U.S. Discharge improves quality of life while eliminating most in-hospital costs for this portion of their care.

In Q2 2009, SynCardia plans to submit applications for CE approval of the Freedom driver in Europe and to the FDA to conduct an IDE clinical study of the Freedom driver in the U.S.

CAUTION – The Freedom® driver is an investigational device, limited by United States and EU law to investigational use.

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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 1,000 implants of the Total Artificial Heart, accounting for more than 250 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