User Manual Part 4

G-2
CLINICAL STUDY - VITALITY
Results
A total of 100 patients were enrolled in this study. Of these, 96 patients were
successfully implanted, with 4 intents. Ninety-three (93) patients finished their
1-month follow-up per the study protocol. All primary and secondary endpoints
of this study were met. The results from this study provide evidence of the
safety and effectiveness of the VITALITY with Automatic Intrinsic Rhythm ID
algorithm (Table G-1 on page G-2).
Table G-1. VITALITY Chronic Study Results
Safety Endpoints
VT/VF Detection Time
3.43 seconds
Primary Endpoints
Sensitivity
Induced VT/VF 100%
Spontaneous VT/VF 100%
Specificity––Induced
Rhythm
Physician/Annotation Device Decision–SVT Specificity
Atrial Fibrillation 71 68
95.8%
Atrial Flutter 94 88
93.6%
Sinus Tachycardia
75
71.4%
Total Induced 172 161
93.6%
Specificity–Spontaneous
Rhythm
Physician/Annotation Device Decision–SVT Specificity
Atrial Fibrillation 65 65
100%
Atrial Flutter 31 28
90.3%
Sinus Tachycardia
37 32
86.5%
Other
77
100%
Total S pontan eous
140 132
94.3%
a
Combined
Specificity
b
312 293
93.9%
Secondary Endpoints
Acute A utomatic Rhythm ID Accuracy (2 weeks) 100%
- DRAFT -