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 SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device. 

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

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