Berlin Heart received HDE approval by the U.S. Food and Drug Administration (FDA) for the EXCOR Pediatric in December 2011. As the sole condition of approval, a Post Approval study was conducted which enrolled 39 subjects. The final study report was submitted to FDA in February 2017.
*Successful transplant or wean of those who met an endpoint; Failure if escalated to other support or weaned from support and died within 30 days
Figure 1 displays the competing outcomes for the All implant Group. The curves represent each of the outcomes and at any time point the sum of the proportions of outcomes equals 100%.
Figure 1. Competing Outcome Plot (n=565)