The Berlin Heart Group has completed enrolment in their post approval study, the only condition that the company had to meet before receiving humanitarian device exemption (HDE) for their EXCOR paediatric ventricular assist device (VAD), set in December 2011.
The post approval study is designed to evaluate whether the safety and outcomes of the EXCOR paediatric VAD in a commercial setting were comparable with safety and outcomes of the device in the IDE study.
The EXCOR paediatric VAD is a mechanical cardiac support system for critically ill paediatric patients of all age groups, from newborns to teenagers suffering from severe heart failure.
The system is intended to bridge patients awaiting heart transplantation from days to several months, until a donor heart becomes available.
Developed in Germany, the EXCOR paediatric VAD is the only device that is approved specifically for the padiatric patients in the US.
The EXCOR paediatric VAD has been CE approved since 1996, as well as approved for use in Canada.
A total of 39 subjects had the device impanted per the approved labelling and were enrolled in the study.
Out of the 39 subjects, 34 have reached an endpoint. As soon as the remaining subjects reach an endpoint, the study data will be analysed and presented to the FDA.
Berlin Heart president and CEO of North American operations 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 paediatric approval in a very short period of time.
"As the EXCOR paediatric 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 favourably."
Berlin Heart develops, produces and distributes implantable and external ventricular assist devices (VADs) for patients of every age and body size.
It also provides pumps, cannulas and external components for internal and external use to stabilise cardiac activity in acutely ill patients.