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Tucson, Ariz.-April 12, 2007 –
SynCardia Systems, Inc., manufacturer of the world’s only FDA and CE Mark
approved temporary Total Artificial Heart (TAH-t), is announcing the availability
for clinical investigation of a portable driver that is designed to allow stable
U.S. patients to recover at home while they wait for their donor heart for transplant.
"The Companion Driver is the first pulsatile driver
intended to fully support patients from implant through discharge and back to
the hospital for transplant,” explains SynCardia’s CEO and President,
Rodger G. Ford.
For OR and ICU applications, the Companion Driver is
designed to be docked into a hospital cart that features a large 15” monitor
intended to be viewed from across a room. For stable patients to be discharged,
the Companion Driver is designed to be “re-docked” into a smaller
caddy that features large wheels and an adjustable handle intended to facilitate
patient mobility. The Companion Driver is designed to function in both hospital
and discharge environments.
"The Companion has been designed to be an adaptable
driver,’” said Dr. Marvin Slepian, SynCardia’s Chairman.
"SynCardia is leading the technology curve. This
driver is intended to support not only the world’s only TAH-t, but also
the planned SynCardia family of pulsatile devices that are currently in development.”
SynCardia met with FDA in March to informally review
the company’s plan to submit an application to conduct an IDE clinical trial
of the Companion Driver at U.S. transplant centers.
All nine TAH-t Certified Centers in the U.S. including
Cleveland Clinic, Hospital University of Pennsylvania, Ohio State, University
of Michigan, etc. have expressed interest in being considered for participation
in this clinical trial. U.S. transplant hospitals interested in being part of
the clinical study should contact the SynCardia Director of Global training and
support, Mary Pat Sloan.
Sloan and the entire SynCardia management team will be
available at the SynCardia ISHLT booth. This year’s display will feature
the Companion Driver, Hospital Cart and Discharge Caddy along with models of planned
products currently in development, including a 50cc TAH-t and 30cc and 10cc VADs.
The booth will also feature a High Definition time-lapse video of a TAH-t implant
surgery filmed by National Geographic photographer Robert Clark. The surgery was
conducted at the German Heart Center Berlin by Professor Roland Hetzer.
# # #
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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