Built by the Giants of Medicine, CardioWest(TM) Artificial Heart Celebrates 60th Birthday

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Sixty years ago, Willem J. Kolff, M.D., Ph.D., the world's most accomplished and prolific creator of artificial organs, started work that led to the creation of the world's first and only FDA and CE approved temporary artificial heart: the CardioWest(TM) temporary Total Artificial Heart (TAH-t). Besides inventing the artificial heart, Dr. Kolff also invented the artificial kidney, and was instrumental in the development of the artificial eye, artificial ear, artificial arm and the heart-lung machine.

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The keys to widespread use of the artificial heart are to have the majority of insurance plans, including Medicare, cover the artificial heart and to work with the FDA to make a discharge driver available in the States.

    On August 31, Tucson-based SynCardia Systems, Inc., manufacturer of the TAH-t, loaned the Kolff Museum the modern version of what Kolff started in 1947. The CardioWest TAH-t was presented by SynCardia's Vice President of Clinical Support, Steve Langford, at the 2007 Willem Kolff Symposium in Kampen, the Netherlands. Langford started with the artificial heart in 1983 when it was called the Jarvik 7 and worked with Dr. Kolff and Dr. Robert Jarvik. Since 1985, Langford has worked with Dr. Jack Copeland at University Medical Center in Tucson where the heart was subsequently renamed the CardioWest TAH-t.

"The CardioWest artificial heart resulted from decades of work by the giants in artificial organs and medicine," Langford explained. "From 1993 to 2002, the TAH-t was in one of the longest clinical studies in FDA history. Today there are 22 TAH-t certified centers, 11 in the U.S. and 11 in Europe. Currently there are 27 patients on the TAH-t: six patients in the U.S. and 21 in Europe."

"We believe there are over three times more hearts being implanted in Europe today because of the TAH-t portable driver," said Rodger Ford, SynCardia president and CEO. "The keys to widespread use of the artificial heart are to have the majority of insurance plans, including Medicare, cover the artificial heart and to work with the FDA to make a discharge driver available in the States."

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. Discharge virtually eliminates in-hospital costs, and allows stable TAH-t patients to lead near normal lives with their families and friends while they wait for a donor heart.

The CardioWest TAH-t is currently approved as a bridge to transplant for patients dying of end stage biventricular failure. These patients are often days, if not hours from death. Their survival depends on receiving a donor heart transplant, 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.ago, Willem J. Kolff, M.D., Ph.D., the world's most accomplished and prolific creator of artificial organs, started work that led to the creation of the world's first and only FDA and CE approved temporary artificial heart: the CardioWest(TM) temporary Total Artificial Heart (TAH-t). Besides inventing the artificial heart, Dr. Kolff also invented the artificial kidney, and was instrumental in the development of the artificial eye, artificial ear, artificial arm and the heart-lung machine.

On August 31, Tucson-based SynCardia Systems, Inc., manufacturer of the TAH-t, loaned the Kolff Museum the modern version of what Kolff started in 1947. The CardioWest TAH-t was presented by SynCardia's Vice President of Clinical Support, Steve Langford, at the 2007 Willem Kolff Symposium in Kampen, the Netherlands. Langford started with the artificial heart in 1983 when it was called the Jarvik 7 and worked with Dr. Kolff and Dr. Robert Jarvik. Since 1985, Langford has worked with Dr. Jack Copeland at University Medical Center in Tucson where the heart was subsequently renamed the CardioWest TAH-t.

"The CardioWest artificial heart resulted from decades of work by the giants in artificial organs and medicine," Langford explained. "From 1993 to 2002, the TAH-t was in one of the longest clinical studies in FDA history. Today there are 22 TAH-t certified centers, 11 in the U.S. and 11 in Europe. Currently there are 27 patients on the TAH-t: six patients in the U.S. and 21 in Europe."

"We believe there are over three times more hearts being implanted in Europe today because of the TAH-t portable driver," said Rodger Ford, SynCardia president and CEO. "The keys to widespread use of the artificial heart are to have the majority of insurance plans, including Medicare, cover the artificial heart and to work with the FDA to make a discharge driver available in the States."

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. Discharge virtually eliminates in-hospital costs, and allows stable TAH-t patients to lead near normal lives with their families and friends while they wait for a donor heart.

The CardioWest TAH-t is currently approved as a bridge to transplant for patients dying of end stage biventricular failure. These patients are often days, if not hours from death. Their survival depends on receiving a donor heart transplant, 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.</DataContent>

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