Healthcare Industry News:  SynCardia Systems 

Devices Cardiology

 News Release - July 26, 2006

100th Implant of CardioWest(TM) Temporary Total Artificial Heart by German Hospital That Pioneered the Use of the Portable Driver Accelerates Artificial Heart Use

BAD OEYNHAUSEN, Germany--(HSMN NewsFeed)--July 26, 2006--The Heart and Diabetes Center NRW, Bad Oeynhausen, Germany, performed its 100th implant of the CardioWest(TM) temporary Total Artificial Heart (TAH-t) on June 30, and their 101st implant on Thursday, July 13.

From 2003-2006, this implant center pioneered the use of the Excor portable driver by conducting a clinical study. That work resulted in the granting of a CE mark for use of the TAH-t with the portable Excor TAH-t driver in Europe, on July 19, 2006.

The external pneumatic driver provides precisely calibrated air pulses that make the world's only FDA- and CE-approved temporary Total Artificial Heart pump blood much like a human heart.

"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 Senior Physician Dr. Aly El Banayosy, head of the Artificial Heart Program at Bad Oeynhausen, who initiated the use of the portable driver and managed the study for the CE mark.

In the United States, transplant centers anticipate an increased use of the TAH-t once a portable driver is available. "Twenty to 25% of the current LVAD market could greatly benefit from the CardioWest(TM) TAH-t, and with the advent of a reliable portable driver, the center could implant upwards of 150-200 CardioWest devices," explained Dr. Francis D. Pagani, director, University of Michigan Transplant Center.

According to a 2005 report published by Medtech Insight, L.L.C., there were 2,500 VAD devices implanted in 2004. They project that ventricular assist device (VAD) implants will to grow to 7,000 in 2010 and 9,000 by 2012. VADs are used to increase blood flow for patients with failing hearts.

The CardioWest TAH-t pumps more blood than any VAD, up to 9.5 liters per minute, and because the TAH-t replaces the heart, there are no complications from failing ventricles that may occur with a VAD.

The TAH-t portable driver is about the size of an attache case and weighs only 20 pounds. The portable driver makes it possible for stable patients to recover at home, and allows many patients to leave home to shop, visit friends, and enjoy a fuller quality of life while waiting for a heart transplant.

The older, 400-pound, washing machine-sized driver, "Big Blue," requires patients to remain in the hospital until a donor heart is available. This could be months in the United States and up to two years in Europe.

The portable driver is not approved by the FDA for use in the United States at this time. SynCardia, the manufacturer of the TAH-t, is reviewing information from European centers and Berlin Heart, AG, manufacturer of the Excor TAH-t portable driver, in preparation for an FDA submission to use the driver in the United States.

A New England Journal of Medicine paper published on Aug. 26, 2004 states that, in the pivotal study of the TAH-t, the one-year survival rate for patients receiving the CardioWest(TM) TAH-t was 70 percent, versus 31 percent for control patients who did not receive the device.

The TAH-t is available to TAH-t certified centers through SynCardia Systems Inc. and in France through IST Cardiology. The best heart transplant hospitals in the world continue to become certified to implant the TAH-t through a three-part training program that concludes with a proctored implant of the TAH-t center being certified. Instructors for the TAH-t certification training program include Marvin J. Slepian, M.D., chairman of the board of SynCardia Systems Inc., chief scientific and medical officer, Richard G. Smith, MSEE, CCE, chief technical officer and cardiothoracic and TAH-t surgeon Jack Copeland, M.D.

Source: SynCardia Systems

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