14 HVAD® Instructions for Use
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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
1.7 Pivotal US Clinical Study: Bridge-to-Transplant (continued)
Exposure
The total support (exposure) on the original HeartWare
™
HVAD
™
System was 20,698 days or
56.7 patient-years. The mean duration on device for the 140 subjects was 147.8 days (standard
deviation 52.8) with a median 180 (range 6 – 180 days). The mean duration on study was 222.5
days (standard deviation 119) with a median of 196 (range 11 – 588 days). Duration on study
exceeds duration on device, because the follow-up post-transplant is included.
Adverse Events
A total of 776 events (Table 3) were reported by investigators during the 180 day period on the
was reported during the 180-day primary endpoint period.
Table 3: Summary of All Investigator-Reported Adverse Events
Event Total %
437 56.3%
338 43.6%
UADE 1 0.1%
Total 776 100%
INTERMACS Events
summarized below and are separated into the perioperative (0-30 days) and post-perioperative
Table 4. Bleeding,
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