Healthcare Industry News:  SynCardia Systems 

Devices Cardiology

 News Release - August 30, 2006

University Hospital of Cologne to be Certified to Implant CardioWest(TM) temporary Total Artificial Heart

Sixth in Germany -- 17th in the World

TUCSON, Ariz.--(HSMN NewsFeed)--Aug. 30, 2006--On Sept. 4 and 5, Dr. Thorsten Wahlers, director and chief surgeon of the department of cardiothoracic surgery, and members of the cardiac transplant team from the University Hospital of Cologne in Germany will begin training to implant the CardioWest(TM) temporary Total Artificial Heart (TAH-t). The first of a three-part certification program will be conducted at the Charite University of Medicine in Berlin.

The CardioWest(TM) TAH-t is currently available in Europe and North America. With the completion of the certification by Cologne, the number of TAH-t implant centers in Germany will increase to six hospitals, second only to the United States, with eight certified centers.

University Hospital of Cologne is a 1,500-bed facility serving 200,000 patients annually. Also attending class will be transplant team members from Leipzig Heart Center in Germany. This group will be updating their certification with training on the portable ExcorŽ TAH-t mobile driver.

The increase in the number of European centers is the result of the availability of the ExcorŽ TAH-t mobile driver, which SynCardia received the CE mark for use in Europe on July 17, 2006. The portable driver is about the size of an attache case and weighs only 20 pounds. This driver allows stable TAH-t patients to recover at home, which speeds recovery and dramatically lowers costs. The driver allows patients to shop, visit friends and enjoy a fuller life while they wait for a donor heart transplant.

SynCardia Systems Inc., manufacturer of the CardioWest(TM) TAH-t, is in the process of preparing documents for an FDA submission to use the portable driver in the United States.

Cardiothoracic surgeon Dr. Walter Pae, of Penn State Milton S. Hershey Hospital, said, "With the availability of a portable driver allowing hospital discharge, the CardioWest(TM) TAH-t will benefit perhaps 25% of the bridge to transplant patients currently treated with LVADs."

The CardioWest(TM) TAH-t is a modern version of the Jarvik-7 Artificial Heart that was first implanted in Barney Clark in 1982. In the 1990s the device and technology were moved to University Medical Center in Tucson, and subsequently renamed the CardioWest(TM) temporary Total Artificial Heart. SynCardia was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and surgeon Jack Copeland, M.D.

Source: SynCardia Systems

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