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Tucson, Ariz.-October 13, 2006 - October
15th marks the second anniversary of the FDA approval of the CardioWest™
temporary Total Artificial Heart (TAH‑t). The TAH‑t is the world’s first
and still the only FDA approved temporary Total Artificial Heart. The artificial
heart is used as a bridge to transplant for transplant eligible patients who are
dying from end-stage biventricular heart failure.
TAH‑t certified centers include many ranked by the US
News and World Report 2006 Best Heart Hospital List: Cleveland Clinic, #1; Hospital
University of Pennsylvania, #13; University Medical Center, Tucson AZ, #16; University
of Michigan, #22; and Ohio State, #39. Next month, Barnes-Jewish in St. Louis,
#10, will begin the TAH‑t certification process. World class centers in Europe
include: Bad Oeynhausen - Heart and Diabetes Center NRW, the German Heart Institute
in Berlin, Groupe Hospitalier La Pitié-Salpêtrière in Paris,
and Hôpital Guillaume et René Laennec in Nantes.
"We started the year with eight TAH‑t certified
centers. By the close of 2006 we will have more than doubled to 21 hospitals:
ten in the U.S. and eleven in Europe. The TAH‑t has been proven through 650 patient
implants world wide," explained Rodger Ford, President and CEO of SynCardia
Systems, Inc., manufacturer of the TAH‑t.
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.
The TAH‑t is a modern version of the Jarvik-7 Artificial
Heart that was implanted in Barney Clark in 1982. In the 1990s the device and
technology moved to University Medical Center (UMC) in Tucson and was subsequently
renamed the CardioWest™ temporary Total Artificial Heart. SynCardia Systems,
Inc. was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE,
and surgeon Jack Copeland, M.D.
# # #
Media contact:
SynCardia Director of Communications
Donald 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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