|
Bad Oeynhausen, Germany-July 26, 2006 - The Heart
and Diabetes Center NRW, Bad Oeynhausen, Germany, performed its 100th implant
of the CardioWestTM temporary Total Artificial Heart (TAH‑t) on June 30th,
and their 101st implant on Thursday, July 13th.
From 2003-2006, this implant center pioneered the use
of the Excor portable driver by conducting a clinical study. That work resulted
in the granting of a CE mark for use of the TAH‑t with the portable Excor
TAH‑t driver in Europe, on July 19, 2006.
The external pneumatic driver provides precisely calibrated
air pulses that make the world's only FDA and CE approved temporary Total Artificial
Heart pump blood much like a human heart.
"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 Senior Physician, Dr. Aly El Banayosy,
Head of the Artificial Heart Program at Bad Oeynhausen, who initiated the use
of the portable driver and managed the study for the CE mark.
In the U.S., transplant centers anticipate an increased
use of the TAH‑t once a portable driver is available. "Twenty to 25% of
the current LVAD market could greatly benefit from the CardioWest™ TAH‑t,
and with the advent of a reliable portable driver, the center could implant upwards
of 150-200 CardioWest devices," explained Dr. Francis D. Pagani, Director, University
of Michigan Transplant Center.
According to a 2005 report published by Medtech Insight,
L.L.C., there were 2,500 VAD devices implanted in 2004. They project that ventricular
assist device (VAD) implants will to grow to 7,000 in 2010 and 9,000 by 2012.
VADs are used to increase blood flow for patients with failing hearts.
The CardioWest TAH‑t pumps more blood than any
VAD, up to 9.5 liters per minute, and because the TAH‑t replaces the heart,
there are no complications from failing ventricles that may occur with a VAD.
The TAH‑t portable driver is about the size of
an attaché case and weighs only 20 pounds. The portable driver makes it
possible for stable patients to recover at home, and allows many patients to leave
home to shop, visit friends, and enjoy a fuller quality of life while waiting
for a heart transplant.
The older, 400 pound, washing machine sized driver, "Big
Blue," requires patients to remain in the hospital until a donor heart is available.
This could be months in the U.S. and up to two years in Europe.
The portable driver is not approved by the FDA for use
in the U.S. at this time. SynCardia, the manufacturer of the TAH‑t, is reviewing
information from European centers and Berlin Heart, AG, manufacturer of the Excor
TAH‑t portable driver, in preparation for an FDA submission to use the driver
in the U.S.
A New England Journal of Medicine paper published on
August 26, 2004 states that, in the pivotal study of the TAH‑t, the one
year survival rate for patients receiving the CardioWestTM TAH‑t was 70
percent, versus 31 percent for control patients who did not receive the device.
The TAH‑t is available to TAH‑t certified
centers through SynCardia Systems, Inc. and in France through IST Cardiology.
The best heart transplant hospitals in the world continue to become certified
to implant the TAH‑t through a three-part training program that concludes
with a proctored implant of the TAH‑t center being certified. Instructors
for the TAH‑t certification training program include Marvin J. Slepian,
M.D., Chairman of the Board of SynCardia Systems, Inc., Chief Scientific and Medical
Officer, Richard G. Smith, MSEE, CCE, Chief Technical Officer and Cardiothoracic
and TAH‑t 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. Banayosy:
http://www.syncardia.com/3245dowloads/drelalybany.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.
MULTIMEDIA AVAILABLE:
- Resources for Reporters
|
