The Excor Pediatric VAD is a mechanical cardiac support system which is designed to support pediatric patients awaiting for heart transplantation.
Berlin Heart North American operations president and CEO Bob Kroslowitz said the FDA worked effectively with them to refine the design of the clinical trial that resulted in a meaningful study with useful conclusions.
The Berlin Heart Excor Pediatric VAD study national principal investigator, Texas Children’s Hospital Congenital Heart Surgery surgeon-in-chief and head Surgery and Baylor College of Medicine Pediatrics professor Charles Fraser said the study involved an incredible effort from 15 centers across North American with extensive experience in pediatric heart failure and transplantation and should serve as a model for future collaborative device investigations involving children, industry, medicine, and the FDA.
