28 HVAD® Instructions for Use
10
9
8
7
6
5
4
3
2
1
Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
1.8 US Clinical Study: Destination Therapy (continued)
Figure 7:4) and alive on the
originally implanted device, or transplanted or explanted for recovery in the overall study dataset.
The post hoc comparison of sintered and non-sintered HVAD
®
Pumps in the interim analysis
cohort did not demonstrate markedly different results (See Figure 8A, 8B).
Figure 8: Comparison of Outcomes from the Interim analysis of Subjects with Sintered Pumps Compared to
or transplanted or explanted for recovery in A) the subset of subjects receiving a sintered HVAD
®
Pump, compared to Control, and in B) the subset of subjects receiving the non-sintered HVAD
®
Pump. This analysis is based on the as-treated population.
A) Sintered: