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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.

Efficacy and Safety

The benefit of the EXCOR® Pediatric Ventricular Assist Device is discussed in a number of publications (s. bibliography). There are two important prospective North-American studies – the EXCOR® Pediatric IDE Study and the EXCOR® Pediatric Post Approval Study that  emphasize the safety and efficacy of the Berlin Heart device.

IDE Study

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



  • The survival at 30 days in cohort 1 was 96% (46% transplanted, 50% on support) for the EXCOR® Pediatric VAD group and 75% (off ECMO) for the ECMO group.
  • In cohort 2, the 30-day survival was 96% (21% transplanted, 4% weaned, 71% on support) for the EXCOR® Pediatric VAD group and 67% (off ECMO) for the ECMO group.
  • In the EXCOR® Pediatric VAD group, all patients were off the device at 174 days in cohort 1 and 192 days in cohort 2, respectively. Overall, 88% in cohort 1 and 92% in cohort 2 were bridged to transplant or recovery with acceptable neurological outcome,respectively. In the ECMO group, for cohort 1 and 2 the longest time of support was 21 days and 28 days, respectively. 25% and 33% of the patients had died on ECMO support in cohort 1 and 2, respectively.

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.

Pre-Market Approval

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)