Major Milestone Achieved - Berlin Heart EXCOR Pediatric IDE Study

Main Category: Heart Disease
Also Included In: Pediatrics / Children's Health;  Medical Devices / Diagnostics
Article Date: 02 Sep 2009 - 3:00 PDT

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Berlin Heart Inc. reported that it has completed enrollment in Cohort 1 of the Berlin Heart EXCOR(R) Pediatric IDE Study after having received unconditional approval of the study 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, CEO 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 outstanding 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.

About EXCOR Pediatric

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.

About Berlin Heart

Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices for patients of every age and body size. The company is market leader in Germany and Europe. The company also manufactures the implantable left ventricular assist device INCOR(R), which has been designed for long-term application in adult patients. The longest the device has supported a patient so far is more than six years. INCOR is not FDA approved, but widely used in Europe.

Source: Berlin Heart GmbH

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