Berlin Heart Completes Post-Approval Surveillance

Berlin Heart Inc. has completed the Post Approval Surveillance for the EXCOR Pediatric Ventricular Assist Device, a requirement of the Post Market Approval (PMA) granted by the U.S. Food and Drug Administration (FDA), in June 2017. The final report submitted to the FDA confirmed the positive contemporary results of treating pediatric heart failure patients with the EXCOR Pediatric VAD System. The reported stroke rate of 11 percent and a mortality rate of 12.5 percent within this FDA-mandated surveillance not only fulfilled the primary objectives of the study, but also exceeded the pre-specified performance goal. In addition, the safety and efficacy of the EXCOR Pediatric VAD fulfilled all other defined study end points.
 
Since the PMA for the Berlin Heart EXCOR Pediatric VAD System was granted by the FDA, more than 270 patients have been supported with the device in North America. “The 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,” according to Bob Kroslowitz, president and CEO of Berlin Heart Inc. “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.”
 
“ACTION is committed to working with all stakeholders, including industry partners such as Berlin Heart, to improve the outcomes of children that require device support. Our community has come together to learn and to change practice where necessary. There is no competition, only collaboration. We are excited to share these results and are also excited to see how far our collaboration can take us to improve the care for all children with heart disease,” commented Angela Lorts, M.D., MBA, and David Rosenthal, M.D., co-founders of ACTION.
 
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 nine months [0.13 – 196.7], with a mean weight of 8 kg [2.7 – 60.3].
 
The results of the Post Approval Surveillance confirm the contemporary success and improved clinical results reported with the EXCOR Pediatric VAD, showing a clear improvement in the EXCOR Pediatric experience when compared to previously published results of stroke rates exceeding 20 percent.