December 4, 2007- Berlin Heart announced the first patient enrollment in the prospective IDE study for its EXCOR Paediatric VAD, a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure.
The EXCOR Paediatric VAD is a pulsatile, pneumatically driven ventricular assist device and can reportedly be used to support one or both ventricles. The multi-center IDE study is to evaluate the safety and probable benefit of using the VAD to support pediatric patients.
The FDA 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 eight-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 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 Paediatric, twelve of them under the compassionate use regulations.
Dr. Jaquiss commented: "We are very pleased the first EXCOR 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 Peadiatric 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 Paediatric has been used as a medium- to long-term support system, supporting failing hearts for up to several months.
For more information: www.berlinheart.com