Heart surgery patients can recover at home with portable artificial
1 June 2006
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 Berlin Heart's
Excor portable driver recently earned the CE Mark for use with the
CardioWest temporary Total Artificial Heart (TAH-t) in Europe.
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 Big Blue
artifical heart driver
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.
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.
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 the second
quarter of 2006. The Excor driver is not approved by the FDA for use in the
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 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,