Press Release:

Currently, the only FDA-approved driver for powering the Total Artificial Heart is “Big Blue” (right), which confines stable Total Artificial Heart patients to the hospital while they wait for a donor heart transplant.

TUCSON, Ariz. – Nov. 5, 2009 – On Nov. 5, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced it has submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom® discharge driver, designed to power the Total Artificial Heart outside the hospital.

“Stable Total Artificial Heart patients in the U.S. are currently confined to the hospital by the large “Big Blue” hospital driver that powers the heart,” said Rodger Ford, SynCardia president and CEO.

“The IDE submission includes a request to conduct the clinical study at 30 U.S. centers,” said Mary Pat Sloan, VP of Global Training and Customer Support. “While many of our trial sites have been identified, we will be following up with additional transplant centers that have expressed interest in participating in the Freedom driver study.”

Later this month, SynCardia will submit the Freedom driver design dossier to the Notified Body for examination for the CE Mark in Europe.

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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