Berlin Heart announced today that it completed the post-approval surveillance process for its Excor pediatric ventricular assist device (VAD).
Post-approval surveillance is a requirement of the post-market approval that Berlin Heart’s Excor received from the FDA in June 2017. The company’s final report to the FDA confirmed positive results in pediatric heart failure patients treated with the Excor pediatric system.
Berlin Heart reported stroke rate of 11% and a mortality rate of 12.5% within the surveillance, fulfilling the primary objectives of the study and exceeding the pre-specified performance goal, according to a news release.
Previously published results from use of the Excor system included stroke rates exceeding 20%, highlighting the improved clinical results in the latest trial, which used data from 72 patients treated across 19 pediatric centers in North America between April 2018 and April 2020.
Since Berlin Heart received PMA for the Excor system, more than 270 patients have been supported with the device in the U.S., the company said.
“The impressive contemporary results with the Excor pediatric and of this study are in large part attributable to our collaboration with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) who worked closely with Berlin Heart on this study,” Berlin Heart president & CEO Bob Kroslowitz said in the release. “ACTION has harnessed the learning power within the leading children’s hospitals in North America to drive changes in the medical management of the pediatric VAD population and work collaboratively to improve the outcomes for children with heart failure, including children supported with the Excor pediatric.
“The results show once again how important the continuous exchange of experience and collaboration between all stakeholders is for the improvement in the treatment of children supported with the Excor pediatric.”