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NEWS RELEASES
Texas Children’s Hospital, lead study center, announces U. S. Food and Drug Administration approval of EXCOR® Pediatric Ventricular Assist Device for use in United States
The Berlin Heart is the only device for use in
babies and young kids
HOUSTON – (Dec.
16, 2011) – Newborns,
toddlers and teens who suffer
from heart failure and need
heart transplantation to survive
just got a life-saving pediatric
heart pump that buys time and
allows them to grow stronger as
they wait for a donor heart.
Texas Children’s Hospital in
Houston, the lead center in a
17-hospital national
Investigational Device Exemption
(IDE) study on the
German-manufactured Berlin Heart
EXCOR Pediatric Ventricular
Assist Device (VAD), announced
today that the FDA has granted a
Humanitarian Device Exemption (HDE)
approval for the EXCOR to be
used in U.S. children as a
bridge to heart transplantation.
Watch a video on the
significance of the Berlin Heart.
The EXCOR, used to provide
circulatory support to
pediatric patients with
severe heart failure, is the
only VAD approved in the
U.S. for use in babies. The
pump allows pediatric
patients from newborns to
teens to remain active so
they grow stronger and meet
developmental milestones as
they await donor hearts.
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Former Berlin
Heart patient, Brady Burch,
shares a moment with Dr. Charles
D. Fraser, Jr, surgeon-in-chief
at Texas Children’s Hospital in
Houston. Fraser shows Burch the
small heart pump that Fraser
implanted to save Burch’s life
when he was born with a severe
heart defect. Burch, a Corpus
Christi resident, is now six
years old and in school.
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“I am extremely gratified
that the FDA has granted an
HDE approval to the EXCOR
Pediatric VAD,” said Dr.
Charles D. Fraser, Jr,
surgeon-in-chief at Texas
Children’s Hospital,
professor of surgery and
pediatrics at Baylor College
of Medicine and national
principal investigator for
the North American Berlin
Heart EXCOR Pediatric study.
“This ushers in a new era
for children with terminal
heart failure. The medical
community is now able to
offer this life-saving
device to support desperate
children who would not
otherwise survive while
awaiting donor hearts. The
study involved an incredible
effort from 15 U.S.
hospitals and two Canadian
centers with extensive
experience in pediatric
heart failure and
transplantation. It should
serve as a model for future
collaborative device studies
involving children,
industry, medicine and the
FDA.”
Texas Children’s Heart
Center implanted its first
Berlin Heart on Sept. 27,
2005 in one of the smallest
babies to ever receive the
device. Brady Burch, a
Corpus Christi resident, is
now 6 years old and in
kindergarten. Fraser, who
has long advocated that
babies need small heart
assist devices sized just
for them, became proactively
involved. He accompanied
Berlin Heart representatives
to Washington, requesting
that the FDA allow an IDE
study. The FDA agreed to
open a study. The first
pediatric patient was
enrolled in November 2007.
Study background
In January 2008, Texas
Children’s was named the
national lead center for a
12-hospital, 36-month
clinical trial of the Berlin
Heart EXCOR Pediatric VAD.
Fraser was selected as the
National Principal
Investigator (NPI) for the
IDE prospective study. In
2009, five other hospitals
were added to the study.
The EXCOR® pediatric
clinical study is the first
prospective clinical trial
ever conducted to
investigate the safety and
benefit of a VAD in the
pediatric population.
Between 2007 and 2010, the
study enrolled 48 patients
in two cohorts of 24
patients each. Another 200
patients were enrolled in a
“compassionate use” cohort.
Along with Texas Children’s
Hospital, the following U.S.
centers participated in the
IDE study: Arkansas
Children’s Hospital (AR),
Boston Children’s Hospital
(MA), Children’s Healthcare
of Atlanta (GA),Children’s
Hospital of Wisconsin (WI),
The Children’s Hospital of
Denver (CO), Lucille Packard
Children’s Hospital at
Stanford (CA), Mott
Children’s Hospital (MI),
Mount Sinai Hospital (NY),
Pittsburgh Children’s
Hospital (PA), Riley
Children’s Hospital (IN),
Seattle Children’s Hospital
(WA), St. Louis Children’s
Hospital (MO), Children’s
Hospital at the University
of Alabama at Birmingham
(AL), and the University of
Minnesota at Fairview (MN).
As NPI, Fraser worked in
cooperation with all 17
hospitals in collecting and
reporting data to the FDA
regarding the safety and
probable benefit of the
pediatric heart pump. On
July 21, 2011, Fraser led
the IDE study team as they
presented the final data to
an FDA circulatory support
advisory panel who
unanimously recommended that
the device be approved by
the FDA. The final approval
came on Dec. 16, 2011.
“It was a privilege to lead
the many investigators,
coordinators and
administrative personnel
involved in this study,”
said Fraser. “I know the
hospitals and physicians who
took part did it solely
because it was the right
thing to do on behalf of
children who suffer heart
failure.”
About Berlin Heart
Berlin Heart GmbH is
the only company
worldwide that develops,
produces, and
distributes implantable
and external ventricular
assist devices for
patients of every age
and body size. The
company offers pumps,
cannulas, and external
components for internal
and external use to
stabilize cardiac
activity in acutely ill
patients. Its products
are market leaders in
their respective
segments in Germany and
in Europe.
About Texas Children's Hospital
Texas Children's Hospital is committed to a community of healthy children by providing
the finest pediatric patient care, education and research. Renowned worldwide for
its expertise and breakthrough developments in clinical care and research, Texas
Children's is nationally ranked in all ten subspecialties in U.S.News & World Report's
list of America's Best Children's Hospitals. Texas Children's also operates the
nation's largest primary pediatric care network, with more than 40 offices throughout
the greater Houston community. Texas Children's has embarked on a $1.5 billion expansion,
Vision 2010, which includes the Jan and Dan Duncan Neurological Research Institute™,
a comprehensive obstetrics facility focusing on high-risk births and a community
hospital in suburban West Houston. For more information on Texas Children's Hospital,
go to www.texaschildrens.org. Get the
latest news from Texas Children's Hospital by visiting the
online newsroom and on Twitter at
www.twitter.com/texaschildrens.
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