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Tucson, Ariz.-December 12, 2006 –
Led by Prof. Michael Weyand, MD, cardiac surgeon, Dr. Tandler, and members of
the heart transplant team at the Center of Cardiac Surgery Erlangen-Nuremberg
at Friedrich Alexander Hospital, began Certification training to implant the CardioWest™
temporary Total Artificial Heart (TAH‑t) on December 4th.
The training is a four part certification process that
includes the proctored implant of the center’s first CardioWest™ TAH‑t
on Thursday, December 14, 2006.
For some hospitals, it can take months to find an appropriate
patient for the first proctored implant of the TAH‑t. At the Friedrich Alexander
Hospital, that patient is waiting right now. This patient is unlikely to survive
more than a couple of weeks without a TAH‑t implant or a human heart transplant.
Speaking from Monday’s training, Dr. Tandler said
"We already have an excellent candidate for the
artificial heart. We are excited to now have a device
we can use to help him survive to transplant."
The surgery will be performed by Dr. Tandler and proctored
by cardiovascular surgeon Latif Arusoglu, M.D. Arusoglu
has performed over 100 TAH‑t implants at the Heart
and Diabetes Center NRW in Bad Oeynhausen, Germany.
The CardioWest™ TAH‑t is used as a "bridge
to transplant" for transplant eligible patients who: 1) have both sides of
their heart failing, 2) do not respond to other treatments, and 3) are at imminent
risk of death.
In Europe, since July, stable patients have been able
to be discharged with the EXCOR® TAH‑t mobile driver. At-home care speeds
recovery and eliminates in-hospital costs for this portion of their care. Living
at home is also morale booster for patients, whose wait for a donor heart can
take up to 18 months in Europe. The portable driver is about the size of an attaché
case and weighs only 20 pounds. This driver allows many patients to leave home
to shop, visit friends, and live a fuller life.
Now in its 50th year of cardiac surgery, the Friedrich
Alexander Hospital has a robust cardiac program. In April 1969 the center performed
the first coronary artery bypass in German history. In 2000 they started implanting
VADs. Since 1999, the hospital has averaged 10-15 heart transplants annually.
Once certified, the Friedrich Alexander Hospital will become the 20th heart transplant
center in the world certified to implant the CardioWest™ 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 rate survival rates after transplantation
among patients who had received a TAH‑t as a bridge to 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 1990’s the device
and technology moved to University Medical Center (UMC) in Tucson and was subsequently
renamed the CardioWestTM 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. The CardioWest™ TAH‑t is the world’s
first and only FDA and CE approved temporary Total Artificial Heart. The TAH‑t
has been implanted in over 650 patients.
# # #
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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