BERLIN, November 30 /PRNewswire/ -- 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, supportin
|SOURCE Berlin Heart AG|
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