Healthcare Industry News:  SynCardia Systems 

Devices Cardiology

 News Release - August 30, 2007

Thanks to Portable Driver Available Only in Europe German Heart Institute Berlin Surpasses Highest Artificial Heart Implant Total

TUCSON, Ariz.--(HSMN NewsFeed)--With four months left in 2007, on Aug. 28, the German Heart Institute Berlin implanted its 10th CardioWest(TM) temporary Total Artificial Heart (TAH-t) of the year. Previously, its highest annual 12-month total was eight hearts.

The latest implant was performed on a 60-year-old male patient. Currently, there are 26 patients on the TAH-t: six patients in the U.S. and three times as many, 20, in Europe.

"We believe there are three times more hearts being implanted in Europe today because of the TAH-t portable driver," said Rodger Ford, president and CEO of TAH-t manufacturer SynCardia Systems, Inc. "Discharge virtually eliminates in-hospital costs. It allows stable TAH-t patients to lead near normal lives with their family and friends while they wait for a donor heart."

Since July 16, 2006, stable TAH-t patients in Europe have been able to recover at home thanks to the CE approved TAH-t portable driver. SynCardia is working with the FDA to address the need for a discharge driver in the U.S. The driver powers the TAH-t with precisely calibrated pulses of air and monitors artificial heart performance.

"Patients with predominant right heart failure and those with profound cardiogenic shock have a realistic chance to survive with a TAH-t, which is superior to any other method," said Prof. Roland Hetzer, M.D., chairman of the German Heart Institute Berlin. "The CardioWest TAH-t is the only device of this kind available today."

The surgical team from the German Heart Institute Berlin was featured in National Geographic Magazine's February 2007 cover story "Healing the Heart." This issue showcased six full pages of photos of the TAH-t implant surgery performed by Prof. Hetzer, M.D., on 62-year-old Siegfried Streiter on June 8, 2006. Streiter was discharged on the portable driver and is currently awaiting a donor heart for transplant.

The CardioWest TAH-t is the only FDA and CE approved temporary artificial heart in the world. It is approved as a bridge to transplant for patients dying from end stage biventricular failure. Their survival depends on receiving a donor heart, or a TAH-t as a bridge to transplant.

A pivotal clinical study of the TAH-t published in the New England Journal of Medicine (NEJM 2004; 351: 859-867) showed that 79 percent of patients receiving the TAH-t survived to transplant, the highest survival rate for any device in the world. More than 670 patients have received a TAH-t, accounting for more than 110 patient years of life.


Source: SynCardia Systems

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