The post approval study is the only condition of the Humanitarian Device Exemption approval that the company obtained for the Excor pediatric VAD in December 2011.
The study is designed to evaluate whether safety and outcomes of the device in the commercial setting were comparable to the safety and outcomes of the device in the IDE study.
In the all-comers prospective study, a total of 39 subjects have been enrolled who were implanted with the device per the approved labeling. Of the 39 subjects, 34 have reached an endpoint to date.
As soon as the remaining subjects reach an endpoint, the study data will be analyzed and presented to the US Food and Drug Administration.
Berlin Heart’s North American operations president and CEO Bob Kroslowitz said: "We are extremely pleased that we have, with the continued support of our implanting sites, been able to satisfy the final requirement of the EXCOR Pediatric approval in a very short period of time.
"As the EXCOR Pediatric had extensive use prior to the HDE approval (available to all North American sites who requested the device under compassionate use regulations), we are confident that the results of the post approval study will be consistent with the IDE study, and in some areas will trend more favorably."
Berlin Heart has designed the Excor pediatric VAD to support pediatric patients of all age groups, from newborns to teenagers, and is intended to bridge patients awaiting heart transplantation from days to several months, until a donor heart becomes available.
The company claims that Excor, which is already approved in Europe and Canada, is the only ventricular assist device that is designed specifically for the pediatric population to be approved in the US.
