Healthcare Industry News:  CardioWest 

Devices Cardiology Regulatory

 News Release - May 16, 2006

Patients in Europe Can Now Recover at Home with CardioWest(TM) Temporary Total Artificial Heart -TAH-t- & Newly Approved Excor TAH-t Portable Driver

TUCSON, Ariz.--(HSMN NewsFeed)--May 16, 2006--Berlin Heart AG, maker of the EXCORŽ Ventricular Assist Devices for children and adults, has received the CE Mark to market a modified version of its Excor Mobile Driving Unit with the CardioWest(TM) TAH-t in Europe.

The TAH-t is the only FDA-, Health Canada- and CE-approved Artificial Heart in the world. The Artificial Heart is a bridge to transplant for patients with end-stage biventricular heart failure who are waiting for a donor human heart. The pneumatic drivers provide air pulses that make the TAH-t pump blood much like a human heart.

The new Excor TAH-t portable driver is about the size of an attache case and weighs only 20 pounds. It is designed for use following TAH-t implant surgery, by stable patients. The portable driver allows stable patients to recover at home, which speeds recovery, improves quality of life and dramatically lowers costs. In addition, the portable driver enables patients to leave home to shop, and for some, to travel.

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. This could be months, and in Europe, sometimes up to two years.

"The portable driver gives patients more freedom to enjoy a better quality of life ... and because many patients recuperate in the comfort of their homes, hospitalization costs for this portion of their recovery are eliminated," explained Cardiologist Marvin Slepian, M.D., chairman of SynCardia.

A New England Journal of Medicine paper published in August 2004 states that, in the pivotal clinical study of the TAH-t, the one-year survival rate for patients receiving the CardioWest temporary Total Artificial Heart was 70 percent versus 31 percent for control patients who did not receive the device.

SynCardia has applied for its own CE mark which will allow the company to market its TAH-t with the Excor TAH-t in Europe, and anticipates approval in Q2. 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. 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.


Source: SynCardia Systems

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