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
®
PumpOverviewIntroduction
19Introduction
1.7 Pivotal US Clinical Study: Bridge-to-Transplant (continued)
Table 9: Functional Status – 6 Minute Walk
6 Minute Walk Baseline Month 6 Change from Baseline
Distance Walked in Meters
132 75 74
Mean (SD) 89.4 (141.3) 246.0 (203.9) 150.1 (214.1)
Median 0.0 274.0 108.3
Min, Max 0.0, 600.2 0.0, 991.8 -273.1, 700.9
95% CI 65.1, 113.7 199.1, 292.9 100.5, 199.8
Figure 3:
6 Minute Walk Test
Table 10 shows a breakdown of results of patients who walked at both baseline and at 6 months
as well as those patients that did not walk at baseline but did walk at 6 months.
Table 10: 6 Minute Walk – Breakdown of Patients Walking vs. Not Walking at Baseline
HeartWare
™
HVAD
™
System Patients Baseline (m) Month 6 (m)
Patients walking at baseline and at
6 months
any reason) but walking at 6 months
Overall Conclusions from Clinical Data
The HeartWare
™
HVAD
™
prospective, contemporaneous control trial. The purpose of this study was to evaluate the safety
and effectiveness in patients listed for cardiac transplantation with refractory, advanced heart
on the originally implanted HVAD
®
Pump or transplanted or explanted for recovery.
The analysis of the primary endpoint yielded non-inferiority of the HeartWare
™
HVAD
™
System to
the Safety Group and 0.9% for the Per Protocol Group. Each of these limits was less than the
15% non-inferiority margin (p-value <0.0001).
HVAD
®
Pump.
™
HVAD
™
bridge to transplant patients.
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