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Tucson, Arizona.-July 20, 2006 - SynCardia
Systems, Inc. has received a CE mark to market a modified version of the Berlin
Heart, AG EXCOR® Mobile Drive Unit, called the EXCOR TAH‑t, with the CardioWest™
TAH‑t in Europe. The pneumatic drivers provide precisely calibrated air pulses
that make the world's only FDA and CE approved TAH‑t pump blood much like a human
heart.
With the CE mark, the number of EXCOR® TAH‑t drivers
will quickly exceed the current population of 39 older "Big Blue" drivers. The
doubling of the number of drivers will fuel growth in the number of TAH‑t certified
hospitals. SynCardia began 2006 with nine certified TAH‑t heart hospitals worldwide.
This number will increase to 15 hospitals with the certification of the 1,500-bed
University of Muenster hospital, which completed stage one of the three-part training
program at the end of June 2006. SynCardia projects expansion to 27 total hospitals
in 2007 and 62 hospitals in 2008.
The EXCOR® TAH‑t portable driver is about the size
of an attaché case and weighs only 20 pounds. It is designed for use by
stable patients following TAH‑t implant surgery. The portable driver allows stable
patients to recover at home, which speeds recovery and dramatically lowers costs.
The EXCOR® TAH‑t driver allows many patients to leave home to shop, visit
friends and enjoy a fuller quality of life.
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 for transplant. This could be months in the US, and in Europe, up to
two years.
"The portable driver gives patients more freedom to live
life like people with normal human hearts. Recovery at home eliminates hospitalization
costs for this part of their care," explained Dr. Aly El Banayosy, who pioneered
and conducted studies on the use of the EXCOR® mobile drive system to drive
the TAH‑t. The work of Dr. Banayosy and his team on the EXCOR® mobile driver
began early this decade at the Heart and Diabetes Center North Rhine-Westphalia,
in Bad Oeynhausen, Germany. In 2003 they began the clinical study which led to
the CE approval on July 17, 2006.
"If not for Dr. Banayosy's work, SynCardia would not
have mobile drivers today," explains Dr. Marvin J. Slepian, founder and chairman
of SynCardia. "Over the last few years, dozens of patients in Germany have avoided
long hospital stays and recovered at home thanks to Dr Banayosy's efforts."
"Our transplant surgeons tell us that they will go from
implanting a handful of TAH‑t's per center annually, to over a hundred a year
with the availability of the mobile driver. That means much lower costs, happier,
healthier patients and families who get to enjoy their loved ones for years longer,
rather than succumbing to end-stage biventricular failure," said Slepian.
A New England Journal of Medicine paper published in
August 2004 states that, in the pivotal study of the TAH‑t, the one year survival
rate following human heart transplant for patients receiving the TAH‑t was 70
percent versus 31 percent for control patients who did not receive the device.
CE marking on a product is a manufacturer's declaration
that the product complies with the essential requirements of the relevant European
safety legislation. The letters "CE" are the abbreviation of French phrase "Conformité
Européene" which literally means "European Conformity". 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. It used as a bridge to transplant
for patients at risk of imminent death from irreversible biventricular heart failure.
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
For photos of the Excor portable driver:
http://www.syncardia.com/3245dowloads/excore1closeup.html
http://www.syncardia.com/3245dowloads/excore1.html
For photos of Dr. Slepian and Dr. Banayosy:
http://www.syncardia.com/3245dowloads/drelalybany.html
http://www.syncardia.com/3245dowloads/drmarvinslepian.html
For photos of the "Big Blue" driver:
http://www.syncardia.com/3245dowloads/externalconsole.html
http://www.syncardia.com/3245dowloads/danualallen.html
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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