Press Release:

The Companion Driver is an investigational device, limited by United States law to investigational use. The Companion Drive Unit is designed to dock into the Hospital Cart for use in the OR and ICU. Once the CardioWest artificial heart patient is stable, the Drive Unit is designed to be re-docked into the Discharge Caddy so the patient can wait for a matching donor heart at home.

TUCSON, Ariz. – Oct. 15, 2008 – On Oct. 23-30, heart transplant teams from six new European hospitals will train exclusively on the SynCardia Companion Driver System while completing the first of four phases of certification training to implant the CardioWest™ temporary Total Artificial Heart.

“With the new Companion Driver, stable CardioWest patients will be able to recover at home while they wait for a matching donor heart,” said Dr. Bansi Koul, Surgical Director of Heart & Lung Transplantation and Artificial Heart & Aortic Surgery Programs at University Hospital, Lund in Sweden.

In Europe, where artificial heart patients can wait up to two years for a matching donor heart, discharge drivers allow stable CardioWest artificial heart patients to shop, travel, visit friends and enjoy a quality of life comparable to people with healthy human hearts.

Also under development is the Freedom® driver, which is intended to weigh less than 10 lbs. and designed to disappear into a backpack or fanny pack. It is designed to power the artificial heart through dual interchangeable batteries for improved patient mobility.

The Companion Discharge Caddy is designed to allow stable CardioWest artificial heart patients to recover at home. Discharge drivers allow patients to shop, travel, visit family and friends and enjoy a quality of life comparable to people with healthy human hearts.

The six European hospitals will be the 37th, 38th, 39th, 40th, 41st and 42nd centers worldwide to start the certification process to implant the CardioWest artificial heart. They include:

#37 UniversitätsKlinikum Heidelberg (Germany)
#38 Ospedale Niguarda Ca’Granda (Milan, Italy)
#39 University Hospital Lund (Sweden)
#40 Kerckhoff Klinik (Bad Nauheim, Germany)
#41 Centre Hospitalier Universitaire et Régional de Tours (France)
#42 Centre Hospitalier Universitaire de Rouen (France)

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

The Companion Driver System is designed to eventually replace the current hospital driver “Big Blue,” which weighs 450 lbs. Patients supported by this driver are confined to the hospital while they wait for a donor heart.

“We, the cardiothoracic transplant team, at University Hospital, Lund, Sweden are pleased to take part in the SynCardia CardioWest training program,” said Dr. Koul. “We believe that the CardioWest artificial heart will allow us to save the lives of more patients dying from end-stage biventricular failure.”

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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