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The multi-center IDE study is to evaluate the safety and probable benefitof using the EXCOR(R) Paediatric VAD to support Paediatric patients. The U.S.Food and Drug Administration granted conditional approval for the prospectiveIDE study to begin initially at 10 centers with 10 patients in May 2007.
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The first patient in the study is an 8-year-old boy suffering from acongenital heart defect. The patient needed a biventricular assist device tosupport his weakened heart until a donor heart becomes available. The childhad been transported from Texas to Arkansas Children's Hospital on an ECMOsystem (extra-corporeal membrane oxygenation) for the procedure.
On 27 November 2007 Dr. Michiaki Imamura, M.D., Ph.D., carried out thesurgery that is reported to have gone well and without complicationsaccording to Dr. Robert Jaquiss, the Principal Investigator for the IDE studyat Arkansas Children's Hospital. The patient is stable and currently in theICU. Arkansas Children's Hospital has so far treated 13 patients withEXCOR(R) Paediatric, twelve of them under the compassionate use regulations.
Dr. Jaquiss commented: "We are very pleased the first EXCOR(R) Paediatricpatient has been enrolled into the IDE study at our center. There is a greatdeal of interest in the medical community that this study proceeds quickly."
EXCOR(R) Paediatric has been designed as a bridge to transplantation forpatients waiting for a suitable donor heart, but has also been used as abridge to recovery when a patient's heart was able to recover and work on itsown again. Unlike standard heart-lung machines, EXCOR(R) Paediatric has beenused as a medium- to long-term support system, supporting failing hearts forup to several months.
Dr. Charles Fraser, M.D., the National Principal Investigator for the IDEstudy, congratulated the team at Arkansas Children's Hospital for proceedingwith the first implant of the Berlin Heart EXCOR Paediatric VAD as part ofthe IDE study: "The initiation of this study represents a giant step forwardin the care of children with critical heart failure. Those of us involved inthis project are excited about the prospect of improved therapies forchildren in desperate need."
Dr. Rolf Kaese, CEO at Berlin Heart, commented: "Enrolling the firstpatient in the EXCOR(R) Paediatric IDE study marks a milestone and brings usone step closer toward obtaining HDE approval. This device fills a real voidas it provides cardiac assist to the smallest patients for whom no realalternative exists."
About EXCOR(R) Paediatric
EXCOR(R) Paediatric is a pulsatile, pneumatically driven ventricularassist 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 fromnewborns with 2 kg to teenagers with 90 kg body weight. The system has beenused 118 times in North-America; with the FDA granting permission on acompassionate use basis.
About Berlin Heart
Berlin Heart is the only company that is able to provide a mid- tolong-term ventricular assist device in the United States for Paediatricpatients of every age and body size. The company manufactures pumps,cannulas, and external components for internal and external use to stabilisecardiac activity in acutely ill patients. Berlin Heart's products INCOR(R),EXCOR(R) and EXCOR(R) Paediatric are market leaders in their respectivesegments in Germany and in Europe. Berlin Heart Inc., the company's USsubsidiary, was founded in 2005 and supports North-American centers under theFDA investigational study. Further product information is available from thecompany websit
