| Muenster, Germany – Oct. 23, 2007– Two months after being implanted with a Left Ventricular Assist Device (LVAD) to support his dying heart, Mike Gadiel’s heart began to fail again. On June 22, surgeons at University of Muenster saved his life by removing both the LVAD and his dying heart, and implanting their first CardioWest™ temporary Total Artificial Heart (TAH-t)
Assisting surgeon PD Dr. Andreas Hoffmeier, CardioWest artificial heart patient Mike Gadiel and his wife, and lead implant surgeon Prof. Dr. T.D.T. Tjan stand outside University of Muenster. Gadiel is able to wait at home for his donor heart because of the European portable driver. Photo (864 KB) |
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This implant marked University of Muenster’s completion of the CardioWest artificial heart certification program, started in 2006. The CardioWest artificial heart is the world’s first and only FDA and CE approved temporary artificial heart. It replaces both the left and right ventricles and pumps up to 9.5 liters per minute, which is more than any other approved device. University of Muenster is the 12th hospital in Europe and the 22nd in the world to become certified to implant the CardioWest artificial heart.
“Because of our CardioWest certification training, we were able to save a patient’s life who otherwise would have been out of options,” said Prof. Dr. Hans Scheld, head of the cardiothoracic department. “When it has been determined that a patient’s heart needs to be replaced, they need a matching donor heart. If one is not immediately available, the best solution for larger patients is the CardioWest temporary Total Artificial Heart.”
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Gadiel was discharged on Sept. 1 from University of Muenster to wait for a donor heart at home. Since July 16, 2006, stable CardioWest patients in Europe have been able to recover at home thanks to the CE approved portable driver. With the driver, many patients are able to shop, travel and visit with friends. SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart, is currently working with the FDA to address the need for a discharge driver in the U.S.
The CardioWest artificial heart is approved as a bridge to transplant for patients dying from end stage biventricular failure. These patients are often days, if not hours from death. Their survival depends on receiving a donor heart, or a CardioWest artificial heart as a bridge to transplant.
The pivotal clinical study of the CardioWest artificial heart published in the New England Journal of Medicine (NEJM 2004; 351: 859-867) showed that 79 percent of patients receiving the artificial heart survived to transplant, the highest survival rate for any heart device in the world.
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Media Contact:
SynCardia Systems, Inc.
Director of Communications
Don Isaacs
cell: 520-955-0660
About the CardioWest™ temporary Total Artificial
Heart
The CardioWest™ TAH‑t is a pneumatic, biventricular, implantable bridge-to-transplant
system for full cardiac replacement, taking the place of the failing heart in
patients at imminent risk of death. The device offers full circulatory support,
the shortest blood path and exposure to artificial surfaces, and the highest level
of cardiac output when compared with other artificial heart systems previously
tested. With the CardioWest™ TAH‑t, patients become better candidates for
eventual transplantation and have post-transplant survival rates equal to that
of non-device cardiac recipients.
About SynCardia Systems
Founded in 2001, SynCardia Systems is the developer of biomechanical cardiac replacement
and assist devices. Its CardioWest™ temporary Total Artificial Heart (TAH‑t)
is designed for severely ill patients with end-stage congestive heart failure.
The device serves as an in-hospital bridge-to-transplantation for patients at
imminent risk of death. SynCardia Systems is based in Tucson, Arizona and is on
the Web at http://www.syncardia.com.
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