User Manual Part 2

E-4
CLINICAL STUDY - VITALITY
complication and two observations reported in the acute study, all of which
were non-investigational device related. No patient deaths were reported.
The VT/VF detection tim e of the VITALITY ICD was f ound to be within two
seconds of the VENTAK PRIZM 2 detection time, leading to the conclusion that
activating the additional VITALITY features does not have a negative effect on
the existing ICD sensing and detection functionality (Table E-2 on page E-4).
Table E-2. Acute study results
Study Endpoint
VITALITY
(Mean ± std)
N
VENTAK
PRIZM 2 DR
(Mean ± std)
N
VT/VF Detection Time (seconds)
3.60 ± 0.60
N=47
3.52 ± .057
N=47
p-value: <0.001
- DRAFT -