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MTB Europe |
Tucson, Arizona USA. Berlin Heart AG, maker of the Excor Ventricular Assist Devices for children and adults, has received the European CE Mark, which allows it to market a modified version of its Excor Mobile Driving Unit with the CardioWest TAH-t in Europe.
The TAH-t has also been approved by the US FDA, Health Canada. 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 attaché 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% versus 31% for control patients who did not receive the device.