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Tucson, Ariz.-May 16, 2006 - Berlin
Heart AG, maker of the EXCOR® Ventricular Assist Devices for children and
adults, has received the CE Mark to market a modified version of its Excor Mobile
Driving Unit with the CardioWest™™ TAH‑t in Europe.
The TAH‑t is the only
FDA, Health Canada and CE approved Artificial Heart in the world. The Artificial
Heart is a bridge to transplant for patients with end-stage biventricular heart
failure who are waiting for a donor human heart. The pneumatic drivers
provide air pulses that make the TAH‑t pump blood much like a human heart.
The new Excor TAH‑t portable driver
is about the size of an attaché case and weighs only
20 pounds. It is designed for use following TAH‑t implant
surgery, by stable patients. The portable driver allows stable
patients to recover at home, which speeds recovery, improves
quality of life and dramatically lowers costs. In addition,
the portable driver enables patients to leave home to shop,
and for some, to travel.
The older, 400 pound, washing machine
sized driver, "Big Blue," is used both in the operating room
and the hospital. Using "Big Blue" to power the TAH‑t requires
patients to remain in the hospital until a donor heart is
found. This could be months, and in Europe, sometimes up to
two years.
"The portable driver gives patients
more freedom to enjoy a better quality of life... and because
many patients recuperate in the comfort of their homes, hospitalization
costs for this portion of their recovery are eliminated,"
explained Cardiologist Marvin Slepian, M.D., Chairman of SynCardia.
A New England Journal of Medicine paper
published in Aug. 2004, states that, in the pivotal clinical
study of the TAH‑t, the one year survival rate for patients
receiving the CardioWest temporary Total Artificial Heart
was 70 percent versus 31 percent for control patients who
did not receive the device.
SynCardia has applied for its own CE
mark which will allow the company to market its TAH‑t with
the Excor TAH‑t in Europe, and anticipates approval in Q2.
The Excor driver is not approved by the FDA for use in the
US.
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 CardioWest™ temporary Total Artificial Heart.
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.
# # #
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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