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NEWS RELEASES
HOUSTON (Jan.
18, 2008) – Texas Children’s has been named the national
lead center for a 12-hospital, 36-month clinical trial of the a
German-manufactured pediatric heart pump called Berlin Heart EXCOR
Pediatric Ventricular Assist Device (VAD).
Charles D.
Fraser, Jr., MD, chief of pediatric and congenital
heart surgery at
Texas Children’s and professor,
Michael E. DeBakey Department of
Surgery at Baylor College of Medicine, will serve as the National
Principal Investigator (NPI) for the Investigational Device Exemption
(IDE)
prospective study. As NPI, Fraser will work in cooperation with10
United States hospitals and 2 Canadian hospitals, in collecting and reporting
data to the United States Food and Drug Administration (FDA) on the safety
and probable benefit of the pediatric heart pump. At the study’s
conclusion, Berlin Heart, Inc. will present those data to the FDA
for consideration of approval of the EXCOR Pediatric VAD for use in
the U.S.
“The Berlin
Heart holds a lot of promise for infants and children whose hearts
are failing,” said Fraser. “It’s extremely gratifying to be part of
such a collaborative study involving the FDA and the other leading
heart centers around the nation in exchanging information that will
ultimately benefit many pediatric heart patients.”
The Berlin Heart
EXCOR Pediatric VAD, which comes in graduated sizes to fit a
pediatric population from newborns to teens, is the only pediatric
heart pump that provides medium-to-long-term mechanical circulatory
support for infants and children awaiting heart transplantations.
The device has been approved in Germany and Europe since 1992, but
does not have FDA approval for use in the U.S.
“The Berlin
Heart is especially attractive as an option for circulatory support
in babies and small children awaiting heart transplantation,” said
Fraser. A particular advantage is that children can get up, walk
around and be kids again while they are recovering and waiting for a
donor heart.”
Along with Texas
Children's Hospital, 11 hospitals will participate in the study:
Arkansas Children’s Hospital, Little Rock; Boston Children’s
Hospital; Children’s Hospital of Wisconsin in Milwaukee; Riley
Children’s Hospital in Indianapolis; Mott Children Hospital in Ann
Arbor; Lucille Packard Children’s at Stanford; St. Louis Children’s
Hospital; Seattle Children’s Hospital; and Children’s Hospital at
the University of Alabama at Birmingham. Stollery Children’s
Hospital in Edmonton and the Hospital for Sick Kids in Toronto are
participating in Canada.
In addition to
the IDE study, Texas Children’s Heart Center has been named the
first Berlin Heart Reference and Training Center in the U.S. – offering support to hospitals not participating in the
study who seek to use the Berlin Heart for the first time.
Dr. David
Morales, pediatric cardiovascular surgeon at Texas Children’s and
assistant professor, Michael E. DeBakey Department of Surgery at
Baylor College of Medicine, will direct a training team comprised of
cardiac surgeons, cardiologists, perfusionists, operating room
nurses, intensive care unit (ICU) nurses, research nurses and a designated Berlin Heart
Fellow. The team will hold periodic training sessions at Texas
Children's, and they will also travel to other hospitals to provide
instruction on-site.
“We are
delighted to have the experienced and dedicated team from Texas
Children’s Heart Center as our first Reference and Training Center
in the U.S.," said Robert H. Halfmann, MD, director clinical science
and reimbursement at Berlin Heart GmbH, Germany. “We are also
pleased to work with Dr. Fraser as the NPI for the EXCOR Pediatric
IDE trial, which is of great importance to us.”
Between 2000 and
2007, prior to FDA approval to begin the study, pediatric hospitals
in the U.S. used the Berlin Heart under the FDA’s emergency or
compassionate-use regulations. Each time a physician wanted to
implant the Berlin Heart in a child dying of heart failure, a
special appeal had to be made to the FDA for approval on a
case-by-case basis. If approved, the Berlin Heart had to be flown
from Germany while the child waited and lost precious time. Also,
under prior FDA regulations, the device could not be stored in the
U.S., but had to be flown back to Germany if it was not used. Now
with the IDE study in place, participating centers may keep the
device on hand for easier access for their patients with failing
hearts.
Background
Physicians in Arizona implanted the first Berlin Heart in the U.S.
in 2000. Later, a 4-month-old baby who received the Berlin Heart at
Stanford University received high-profile coverage in a two-page
feature of the New York Times in August, 2004. The article piqued
interest in the Berlin Heart among pediatric hospitals around the
country.
Texas Children’s Heart Center implanted its first
Berlin Heart on
September 27, 2005 in one of the smallest babies to ever receive the
device. Currently, Texas Children’s has implanted seven Berlin
Hearts in infants and young children between the ages of 2 months
to 12 years. Based on his experience with the device, Fraser, a
strong advocate of small devices for babies, began working with
representatives of the Berlin Heart company in submitting evidence
to the FDA. In May, 2007, the FDA granted a “Conditional
Investigational Device Exemption approval” that allowed for a
multi-center study or clinical trial to be set up.
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
ranked in the top ten best children’s hospitals by U.S. News and
World Report. Texas Children’s also operates the nation’s largest
primary pediatric care network, with over 40 offices throughout the
greater Houston community. Texas Children’s has embarked on a $1.5
Billion expansion,
Vision 2010, which includes a Neurological
Research Institute, a comprehensive obstetrics facility focusing on
high risk births, and a community hospital in suburban West Houston.
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