The multi-center IDE study is designed to evaluate the safety and benefit of using the Excor paediatric VAD to support paediatric patients. The FDA granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients in May 2007.
According to the company, Excor paediatric 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.
Rolf Kaese, CEO of Berlin Heart, said: “Enrolling the first patient in the Excor paediatric IDE study marks a milestone and brings us one step closer toward obtaining HDE approval.”