University Hospital Cologne to be certified to implant CardioWest artificial heart

1 Sept 2006

Tucson, Ariz. USA. Members of the cardiac transplant team from the University Hospital of Cologne in Germany will begin training to implant the CardioWest temporary Total Artificial Heart (TAH-t) on 4 Sept. The first of a three-part certification program will be conducted at the Charite University of Medicine in Berlin.

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

Also attending class will be transplant team members from Leipzig Heart Centre in Germany. This group will be updating their certification with training on the portable Excor TAH-t mobile driver.

The increase in the number of European centres is the result of the availability of the Excor 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 attaché case and weighs only 20lbs. 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 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 TAH-t will benefit perhaps 25% of the bridge-to-transplant patients currently treated with LVADs."

The CardioWest 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 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.


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