Berlin Heart Inc. (Berlin Heart), has completed Cohort 1 patient enrollment for EXCOR Pediatric IDE study which received unconditional approval from the FDA in November 2008.
The principal investigator, Dr. Charles Fraser, Chief of Congenital Heart Surgery at Texas Children’s Hospital and Professor of Surgery and Pediatrics at Baylor College of Medicine said: We are very pleased with the progress of this study. Reaching this extremely important milestone brings us a step closer to understanding the potential of the EXCOR device as a reliable option for children with no hope who are dying from heart failure.
The last two patients implanted in this Cohort were implanted at Texas Children’s Hospital in Houston, Texas by Dr. David Morales and at Children’s Hospital of Wisconsin in Milwaukee, Wisconsin by Dr. James Tweddell.
Dr. Johannes Mueller, chief executive officer of Berlin Heart commented: Berlin Heart is proud that the EXCOR device is the first ventricular assist device to be involved in a prospective clinical trial involving the pediatric population. We are very pleased with the early clinical results of the study and are excited as this milestone brings us closer to our goal of making this device more readily available for sick children in the US.
Bob Kroslowitz, vice president of clinical affairs for Berlin Heart said: This is an achievement for the whole team. We especially thank our study sites, our investigators and most importantly, the families of the children that have been enrolled in the study. We look forward to compiling the results and submitting an application to the FDA for approval for this important group of patients while we continue to enroll additional pediatric patients into Cohort 2 of the study.
Implants of the EXCOR Pediatric device for Cohort 1 patients are continuing under a Continued Access Protocol that was recently approved by the FDA.
The EXCOR Pediatric ventricular assist device is a pulsatile, pneumatically driven cardiac support system for critically ill pediatric patients suffering from severe heart failure. It has been used in more than 600 pediatric patients worldwide ranging from newborns with 2.2 kg body weight to teenagers. EXCOR Pediatric is currently under clinical investigation for pediatric patients in USA.