Healthcare Industry News:  SynCardia Systems 

Devices Cardiology Regulatory

 News Release - July 20, 2006

SynCardia Receives CE Mark to Market EXCOR(R) TAH-t Mobile Driver with CardioWest(TM) Temporary Total Artificial Heart (TAH-t)

TUCSON, Ariz.--(HSMN NewsFeed)--July 20, 2006--SynCardia Systems Inc. has received a CE mark to market a modified version of the Berlin Heart, AG EXCORŽ Mobile Drive Unit, called the EXCOR TAH-t, with the CardioWest(TM) TAH-t in Europe. The pneumatic drivers provide precisely calibrated air pulses that make the world's only FDA- and CE-approved TAH-t pump blood much like a human heart.

With the CE mark, the number of EXCORŽ TAH-t drivers will quickly exceed the current population of 39 older "Big Blue" drivers. The doubling of the number of drivers will fuel growth in the number of TAH-t certified hospitals. SynCardia began 2006 with nine certified TAH-t heart hospitals worldwide. This number will increase to 15 hospitals with the certification of the 1,500-bed University of Muenster hospital, which completed stage one of the three-part training program at the end of June 2006. SynCardia projects expansion to 27 total hospitals in 2007 and 62 hospitals in 2008.

The EXCORŽ TAH-t portable driver is about the size of an attache case and weighs only 20 pounds. It is designed for use by stable patients following TAH-t implant surgery. The portable driver allows stable patients to recover at home, which speeds recovery and dramatically lowers costs. The EXCORŽ TAH-t driver allows many patients to leave home to shop, visit friends and enjoy a fuller quality of life.

The older, 400-pound, washing machine-sized driver, "Big Blue," is used both in the operating room and the hospital. Using "Big Blue" to power the TAH-t requires patients to remain in the hospital until a donor heart is found for transplant. This could be months in the United States, and in Europe, up to two years.

"The portable driver gives patients more freedom to live life like people with normal human hearts. Recovery at home eliminates hospitalization costs for this part of their care," explained Dr. Aly El Banayosy, who pioneered and conducted studies on the use of the EXCORŽ mobile drive system to drive the TAH-t. The work of Banayosy and his team on the EXCORŽ mobile driver began early this decade at the Heart and Diabetes Center North Rhine-Westphalia, in Bad Oeynhausen, Germany. In 2003 they began the clinical study which led to the CE approval on July 17, 2006.

"If not for Dr. Banayosy's work, SynCardia would not have mobile drivers today," explained Dr. Marvin J. Slepian, founder and chairman of SynCardia. "Over the last few years, dozens of patients in Germany have avoided long hospital stays and recovered at home thanks to Dr. Banayosy's efforts."

"Our transplant surgeons tell us that they will go from implanting a handful of TAH-ts per center annually to over a hundred a year with the availability of the mobile driver. That means much lower costs, happier, healthier patients and families who get to enjoy their loved ones for years longer, rather than succumbing to end-stage biventricular failure," said Slepian.

A New England Journal of Medicine paper published in August 2004 states that, in the pivotal study of the TAH-t, the one-year survival rate following human heart transplant for patients receiving the TAH-t was 70 percent versus 31 percent for control patients who did not receive the device.

CE marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European safety legislation. The letters "CE" are the abbreviation of the French phrase "Conformite Europeene" which literally means "European Conformity." The EXCOR driver is not approved by the FDA for use in the United States.

The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in Barney Clark in 1982. It is used as a bridge to transplant for patients at risk of imminent death from irreversible biventricular heart failure. In the 1990s the device and technology moved to University Medical Center (UMC) in Tucson and was subsequently renamed the CardioWest(TM) temporary Total Artificial Heart. Budget cutbacks at UMC came close to stopping the study of this technology. To save the TAH-t, SynCardia Systems Inc. was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and cardiovascular surgeon Jack Copeland, M.D.

For photos of the EXCOR portable driver:

http://www.syncardia.com/3245dowloads/excore1closeup.html

http://www.syncardia.com/3245dowloads/excore1.html

For photos of Dr. Slepian and Dr. Banayosy:

http://www.syncardia.com/3245dowloads/drelalybany.html

http://www.syncardia.com/3245dowloads/drmarvinslepian.html

For photos of the "Big Blue" driver:

http://www.syncardia.com/3245dowloads/externalconsole.html

http://www.syncardia.com/3245dowloads/danualallen.html


Source: SynCardia Systems

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