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In 1982, the world became captivated by the
Jarvik-7 Artificial Heart implanted into Barney Clark who
lived for 112 days. In the 90’s the device and technology
moved to University Medical Center (UMC) and was subsequently
renamed the CardioWest temporary Total Artificial Heart (TAH‑t).
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,
M.D.
Today, the CardioWest™ temporary Total
Artificial Heart (TAH‑t) is the only FDA and CE approved
device capable of providing circulatory restoration in morbidly
ill patients with irreversible biventricular failure, bridging
them to transplantation. In 2004, the TAH‑t was
named the number one advance in Cardiovascular Medicine by
the American Heart Association.
A New England Journal of Medicine paper published
on August 26, 2004 (NEJM 2004; 351: 859-867), states that
in the pivotal clinical study of the TAH‑t, the one
year survival rate for patients receiving the CardioWest TAH‑t
was 70 percent versus 31 percent for control patients who
did not receive the device. One-year and five-year survival
rate survival rates after transplantation among patients who
had received a TAH‑t as a bridge to human heart transplant
were 86 and 64 percent.
In 2008, the number of SynCardia Certified Centers increased to 27 worldwide. Some of the world’s finest cardiac
hospitals and surgical teams have become, or are training
to be, SynCardia Certified Centers. As ranked in the U.S. News and World Report "2009 Best Heart & Heart Surgery Hospitals” list, they include #1 Cleveland Clinic, #9 Hospital of the University of Pennsylvania, #12 Barnes-Jewish Hospital,
#16 University
of Michigan Hospitals & Health Centers, #37 Ohio State University Hospital and #44 Virginia Commonwealth University Health System.
In Europe, SynCardia Certified Centers include the Heart and Diabetes Center NRW in Bad
Oeynhausen, Germany, La Pitie in Paris
and the German Heart Institute in Berlin.
On July 17, 2006, SynCardia received CE approval
in Europe to market portable pneumatic driver units that power
the TAH‑t. During the European study of this portable
driver, many patients were able to recover at home, shop and
even travel.
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