| Tucson,
Ariz. – July 17, 2007 – On July
17 and 18, cardiothoracic surgeon Dr. Stephen Clayson,
M.D., and his heart transplant team from LDS Hospital
in Utah, are in Tucson receiving the first phase of
certification training to implant the CardioWest temporary
Total Artificial Heart (TAH-t).
In the 1990s, LDS Hospital was
one of five participating hospitals active in the pivotal
clinical study of the CardioWest TAH-t. On March 17,
2004, during a public meeting with the FDA panel reviewing
the device, cardiothoracic surgeon James Long, M.D.,
spoke in support of the TAH-t. Dr. Long was the founder
and has been the director of the Utah Artificial Heart
Program at LDS Hospital since 1993.
On Oct. 15, 2004, the CardioWest
TAH-t became the first and still only FDA approved temporary
total artificial heart in the world.
The first phase of training is
occurring at University Medical Center in Tucson. The
remaining three phases of TAH-t certification training
take place at the hospital being certified.
The third phase of certification
is the proctored implant of the artificial heart by
artificial heart pioneer Dr. Jack Copeland or another
TAH-t veteran surgeon. LDS and all TAH-t certified hospitals
have years, and often decades, of experience in human
heart transplantation.
In the pivotal clinical study,
the TAH-t had a bridge to transplant success rate of
79 percent (New England Journal of Medicine 2004; 351:
859-867), which is the highest success rate of any heart
assist device in the world.
LDS Hospital, recognized as Utah’s
premier healthcare facility in 2006 by the “Best
of State” program, will join 21 of the world’s
finest transplant hospitals in the U.S., Canada and
Europe that are certified to implant the TAH-t.
# # #
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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