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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.
The number of CardioWest TAH-t certified
implant centers has increased from 9 to 20 centers world wide
in 2006, and plans to increase to 34 in 2007 and 72 hospitals
in 2008. According to SynCardia’s CEO and President,
Rodger Ford, “This growth will convert the company from
a scientific venture into a profitable life-saving business.”
Some of the world’s finest cardiac
hospitals and surgical teams have become, or are training
to be, TAH‑t certified centers. In the U.S., these hospitals
include Cleveland Clinic, ranked #1, Barnes-Jewish Hospital,
#10, Hospital University of Pennsylvania, #13, University
of Michigan, #22, and Ohio State, #39 in the “U.S. News
and World Report 2006 Best Heart Hospitals” list.
In Europe, certified centers include Bad
Oeynhausen - Heart and Diabetes Center NRW, 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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