| Tucson, Ariz. – Sept. 13, 2007 - 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™ temporary Total Artificial Heart (TAH-t).
SynCardia Vice President of Clinical Support for the CardioWest™ temporary Total Artificial Heart (TAH-t), Steve Langford, holds in his right hand (left on photo) the 70cc CardioWest TAH-t, and in his left hand (right on photo) the 1980s 100cc version, known as the Jarvik 7. SynCardia has begun development on a 50cc heart that will be designed to fit a majority of women, adolescents and small adults. |
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Along with 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.
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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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