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 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