Berlin Heart said it has fulfilled the primary objectives of a post-approval surveillance study for its Excor Pediatric heart failure device.
The Woodland, TX-based company said the Excor Pediatric VAD system had a stroke rate of 11% and a mortality rate of 12.5% within this FDA mandated Surveillance.
The objective of this prospective surveillance was to demonstrate the continued safety and effectiveness of the Berlin Heart Excor Pediatric Ventricular Assist Device. Data from 72 patients treated in 19 pediatric cardiac centers in North America between April 2018 to April 2020 were analyzed and summarized in the report. The median age of the patients was 9 months [0.13 - 196.7], with a mean weight of 8 kg [2.7 - 60.3].
“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,” Bob Kroslowitz, President and CEO of Berlin Heart, said in a 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.”