SynCardia
Systems, Inc. is the manufacturer of the CardioWest™
temporary Total Artificial Heart (TAH‑t). It is
the only FDA and CE approved temporary Total Artificial
Heart in the world. It is designed for severely ill
patients with end-stage biventricular failure. The TAH‑t
serves as a bridge to human heart transplant for transplant
eligible patients who are within days or even hours
of death.
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 rates after transplantation among
patients who had received a TAH‑t as a bridge
to human heart transplant were 86 and 64 percent.
On July 17, 2006, SynCardia received CE approval of
the TAH-t portable driver in Europe, allowing patients
to be discharged from the hospital and await their heart
transplant at home. Late in 2007, SynCardia will be
applying to the FDA for a study of a new driver currently
in development in the United States for use both in
the hospital and for discharge.
Some of the world's finest cardiac hospitals and surgical
teams have become 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, University of Muenster, University of Cologne, University
of Munich, La Pitie in Paris, and the German Heart Institute in Berlin. In 2006,
TAH‑t certified implant centers increased from 9 to 20 centers world wide.
SynCardia projects the number of certified centers will expand to 34 in 2007 and
72 in 2008.
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