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Efficacy and Safety
Berlin Heart is your partner during the entire VAD therapy: from the patient selection to the VAD implantation and postoperative management of your patient.
The IDE study, a prospective, multicenter, single-arm study, evaluated the safety of the Berlin Heart EXCOR® Pediatric VAD and compared its efficacy with a historical control population supported with ECMO as a bridge to cardiac transplantation in children. 48 patients of 16 years or younger were divided into two cohorts according to body-surface area: Cohort 1: n=24, BSA <0.7 m2, Cohort 2: n=24, BSA ≥0.7 to <1.5 m2
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.
Following the completion of the post approval study requirement for the HDE approval, Berlin Heart applied for a Post Market Approval (PMA) submitting data on the earlier studies and implants that occurred post HDE approval outside a study. The U.S. Food and Drug Administration (FDA) approved the PMA in June 2017. This approval supersedes the 2011 HDE approval.
Table 1 details the data groups from the PMA. The Study group (n=187) was comprised of the subjects enrolled in the initial IDE study primary cohorts (see IDE summary, n=48) plus the compassionate use subjects at the IDE sites (n=54) and the subjects enrolled in the HDE post approval study (n=39). The Database group (n=320) was comprised of the Study group (n=187) plus the non-IDE site compassionate use subjects (n=133). The All implant group (n=565) was comprised of the Database group (n=320) plus the patients implanted with the device in the commercial setting outside any clinical study.
The subjects in the All implant group were supported for a median of 47 days (range 0-504) and were successfully weaned or bridged to transplant in 73% of the subjects. The rate of ischemic/hemorrhagic events experienced decreased over the years and was only 15.6% in the overall group.
*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)
