40 Hospitals Join Program to Implant SynCardia Total Artificial Heart During Past Year

World's Only Approved Total Artificial Heart Growing into Standard of Care for End-Stage Biventricular Heart Failure

Tucson AZ USA, (PresseBox) - SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that during the past year, 40 hospitals have enrolled in SynCardia's Certification Program to implant the world's only FDA, Health Canada and CE approved Total Artificial Heart.

SynCardia is currently certifying the company's first transplant centers in New York, Boston, Atlanta, Texas, Los Angeles and the Pacific Northwest, in addition to Great Britain, Lithuania and Israel.

"We are very excited to have renowned transplant centers adopt SynCardia's Total Artificial Heart technology, including Texas Children's Hospital, Brigham and Women's Hospital and Papworth Hospital," said Michael Garippa, President/CEO. "With the availability of the Freedom® portable driver, SynCardia's Total Artificial Heart is growing into the standard of care for patients dying from end-stage biventricular failure. We are working to bring the Total Artificial Heart to all major markets across the U.S. and the world."

Once currently enrolled hospitals complete the four-phase certification process, the number of U.S. SynCardia Certified Centers will double to 30, bringing the total number of centers worldwide to 70. In addition to the US, there are currently SynCardia Certified Centers in Australia, Germany, France, Italy, Russia, Turkey, Austria and Canada.

The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. Weighing 13.5 pounds, the Freedom driver is the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is intended to allow stable Total Artificial Heart patients to be discharged from the hospital to wait for a matching donor heart at home and in their communities.

SynCardia Systems Inc

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. Similar to a heart transplant, the SynCardia temporary 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.

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 900 implants of the Total Artificial Heart, accounting for more than 210 patient years of life. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles.

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 lbs, SynCardia's Freedom® portable driver is the world's first wearable driver for powering 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.

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