Press Release:

TUCSON, Ariz. – July 20, 2006 – SynCardia Systems, Inc. has received a CE mark to market a modified version of the Berlin Heart, AG EXCOR® Mobile Drive Unit, called the EXCOR TAH-t, with the CardioWest™ 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 EXCOR® 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 EXCOR® TAH-t portable driver is about the size of an attaché 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 EXCOR® 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 US, 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 EXCOR® mobile drive system to drive the TAH-t. The work of Dr. Banayosy and his team on the EXCOR® 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,” explains 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-t’s 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 French phrase “Conformité Européene” which literally means “European Conformity”. The Excor driver is not approved by the FDA for use in the US.

The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in Barney Clark in 1982. It used as a bridge to transplant for patients at risk of imminent death from irreversible biventricular heart failure. In the 1990’s the device and technology moved to University Medical Center (UMC) in Tucson and was subsequently renamed the CardioWest™ 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.

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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