Press Release:

Prof. Francesco Musumeci, Director of Cardiovascular Department

TUCSON, Ariz. – Sept. 24, 2008 – On Sept. 8 and 9, Prof. Francesco Musumeci, Director of the Cardiovascular Department, cardiothoracic surgeon Antonino Loforte, M.D., and the cardiac surgery team from Azienda Ospedaliera San Camillo Forlanini completed the first phase of certification training for the CardioWest™ temporary Total Artificial Heart (TAH-t) in Berlin, Germany.

Italy’s first implant of the CardioWest artificial heart was performed on Dec. 6, 2007, at Azienda Ospedaliera di Padova in Padova. The patient was discharged from the hospital on the European portable driver on February 4, 2008. He is currently enjoying life at home while he waits for a matching donor heart.

The European portable driver received CE Mark approval on July 17, 2006. It allows stable CardioWest patients to recover at home while they wait for a donor heart. Discharge drivers allow stable artificial heart patients to shop, travel and enjoy a quality of life comparable to people with human hearts.

There is currently no FDA-approved discharge driver in the U.S. For the last 25 years, U.S. CardioWest patients have been confined to the hospital while they wait for a matching donor heart.

Dr. Antonino Loforte, Cardiothoracic Surgeon

In Q4, SynCardia will submit an application to the FDA to conduct an IDE clinical study of the Companion Driver System at 22 U.S. CardioWest certified centers. The Companion Driver is designed for use in both the hospital and for discharge.

Azienda Ospedaliera San Camillo Forlanini will become the 36th hospital in the world and the third in Italy to complete CardioWest certification training. The 270-bed Roman hospital performed 26 heart transplants last year and has performed 19 this year as of Aug. 31. In Rome, Prof. Musumeci has performed more than 1,100 open heart surgeries including 100 heart transplants.

Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. These patients are often days, if not hours from death. Their survival is dependent upon receiving a matching donor heart, or a CardioWest artificial heart as a bridge-to-transplant.

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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.

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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660