Berlin Heart touts pediatric heart device post-approval performance

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 …

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