Press Release:

Dr. Ulf Kjellman, Sahlgrenska University Hospital

TUCSON, Ariz. – Oct. 23, 2008 – On Oct. 15, Dr. Lars Wiklund, chief of cardiothoracic surgery at Sahlgrenska University Hospital in Gothenburg, Sweden, led his surgical team in performing Sweden’s first implant of the CardioWest™ temporary Total Artificial Heart into a 31-year-old male patient. Dr. Ulf Kjellman, head of the ventricular assist device (VAD) program, performed the implant.

“If it weren’t for the CardioWest artificial heart, this patient would have died,” said Dr. Kjellman. “Both sides of his heart were failing. He needed a heart transplant to survive, but no donor heart was available. His only option was for us to implant the CardioWest artificial heart as a bridge-to-transplant. The artificial heart will make him a stronger and healthier transplant candidate while he waits for a matching donor heart.”

In Germany, Hans Walter Thrun was bridged to a human heart transplant after 365 days on the CardioWest artificial heart. While he waited for his donor heart, he was discharged from the hospital using the CE approved portable driver.

In some countries in Europe, artificial heart patients can wait up to two years for a matching donor heart. Since July 16, 2006, stable CardioWest patients in Europe have been able to recover at home thanks to the CE approved portable driver.

“Discharge drivers substantially reduce the costs associated with in-hospital care, while allowing stable CardioWest patients to shop, travel, visit friends and enjoy a quality of life comparable to people with human hearts,” said Dr. Kjellman.

During Q4 2008, SynCardia will apply to the FDA to conduct an IDE clinical study of the Companion Driver System in the U.S. and will also apply for CE approval in Europe. The Companion Driver is designed for use in both the hospital and at home. SynCardia projects a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the 24 months following regulatory approvals.

In Germany, Joachim Heumann was bridged to a human heart transplant after 351 days on the CardioWest artificial heart. A motorcycle mechanic, he affixed a Ducati logo to his CE approved portable driver, which he nicknamed “Anton”.

Sahlgrenska University Hospital is the largest hospital in northern Europe, with more than 2,700 beds and 140 departments. The implant marked the hospital’s completion of the CardioWest certification training program, started Aug. 27, 2007. Sahlgrenska University Hospital is the 26th hospital in the world and the 13th hospital in Europe to become a CardioWest certified center.

Sweden joins Germany, France, Austria and Italy as the fifth European country with a hospital certified to implant the CardioWest artificial heart.

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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