BERLIN, Nov. 30 /CNW/ - Berlin Heart today announced the first patient
enrolment in the prospective IDE study for its EXCOR(R) Paediatric VAD, a
mechanical cardiac support system for critically ill Paediatric patients
suffering from severe heart failure.
The multi-center IDE study is to evaluate the safety and probable benefit
of using the EXCOR(R) Paediatric VAD to support Paediatric patients. The U.S.
Food and Drug Administration granted conditional approval for the prospective
IDE study to begin initially at 10 centers with 10 patients in May 2007.
The first patient in the study is an 8-year-old boy suffering from a
congenital heart defect. The patient needed a biventricular assist device to
support his weakened heart until a donor heart becomes available. The child
had been transported from Texas to Arkansas Children's Hospital on an ECMO
system (extra-corporeal membrane oxygenation) for the procedure.
On 27 November 2007 Dr. Michiaki Imamura, M.D., Ph.D., carried out the
surgery that is reported to have gone well and without complications according
to Dr. Robert Jaquiss, the Principal Investigator for the IDE study at
Arkansas Children's Hospital. The patient is stable and currently in the ICU.
Arkansas Children's Hospital has so far treated 13 patients with EXCOR(R)
Paediatric, twelve of them under the compassionate use regulations.
Dr. Jaquiss commented: "We are very pleased the first EXCOR(R) Paediatric
patient has been enrolled into the IDE study at our center. There is a great
deal of interest in the medical community that this study proceeds quickly."
EXCOR(R) Paediatric has been designed as a bridge to transplantation for
patients waiting for a suitable donor heart, but has also been used as a
bridge to recovery when a patient's heart was able to recover and work on its
own again. Unlike standard heart-lung machines, EXCOR(R) Paediatric has been
used as a medium- to long-term support system, supporting failing hearts for
up to several months.
Dr. Charles Fraser, M.D., the National Principal Investigator for the IDE
study, congratulated the team at Arkansas Children's Hospital for proceeding
with the first implant of the Berlin Heart EXCOR Paediatric VAD as part of the
IDE study: "The initiation of this study represents a giant step forward in
the care of children with critical heart failure. Those of us involved in this
project are excited about the prospect of improved therapies for children in
Dr. Rolf Kaese, CEO at Berlin Heart, commented: "Enrolling the first
patient in the EXCOR(R) Paediatric IDE study marks a milestone and brings us
one step closer toward obtaining HDE approval. This device fills a real void
as it provides cardiac assist to the smallest patients for whom no real
About EXCOR(R) Paediatric
EXCOR(R) Paediatric is a pulsatile, pneumatically driven ventricular
assist device and can be used to support one or both ventricles. EXCOR(R)
Paediatric has been used in a total of 343 Paediatric patients ranging from
newborns with 2 kg to teenagers with 90 kg body weight. The system has been
used 118 times in North-America; with the FDA granting permission on a
compassionate use basis.
About Berlin Heart
Berlin Heart is the only company that is able to provide a mid- to
long-term ventricular assist device in the United States for Paediatric
patients of every age and body size. The company manufactures pumps, cannulas,
and external components for internal and external use to stabilise cardiac
activity in acutely ill patients. Berlin Heart's products INCOR(R), EXCOR(R)
and EXCOR(R) Paediatric are market leaders in their respective segments in
Germany and in Europe. Berlin Heart Inc., the company's US subsidiary, was
founded in 2005 and supports North-American centers under the FDA
investigational study. Further product information is available from the
company website: http://www.berlinheart.com.
For further information:
For further information: Linda Buerk, Berlin Heart GmbH, Phone:
+49(0)30-8187-2650, Cell: +49(0)173-629-0803, Fax: +49(0)30-8187-22-2650,