Berlin Heart Enrolls First Patient in US Multi-Center EXCOR® Pediatric VAD IDE Study
The multi-center IDE study is to evaluate the safety and probable benefit of using the EXCOR® Pediatric VAD to support pediatric 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® Pediatric, twelve of them under the compassionate use regulations.
Dr. Jaquiss commented: "We are very pleased the first EXCOR® Pediatric 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® Pediatric 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®Pediatric 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 Pediatric 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 desperate need."
Dr. Rolf Kaese, CEO at Berlin Heart, commented: "Enrolling the first patient in the EXCOR®Pediatric 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 alternative exists."
About EXCOR® Pediatric
EXCOR® Pediatric is a pulsatile, pneumatically driven ventricular assist device and can be used to support one or both ventricles. EXCOR® Pediatric has been used in a total of 343 pediatric 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.
Berlin Heart GmbH
Berlin Heart is the only company that is able to provide a mid- to long-term ventricular assist device in the United States for pediatric 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®, EXCOR® and EXCOR® Pediatric 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: www.berlinheart.com.
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