COOK Medical Zilver Mode D'emploi page 12

Table 6: Rates for All Major Adverse Events within 9 Months Post-Procedure
All enrolled patients
Evaluable patients
1
5 patients who could not be assessed at 9 months (i.e., 1 withdrawn and 4 lost to follow-up) were imputed as
experiencing MAE as a worst case analysis.
2
Major adverse events in 7 of the 11 patients reported with MAE were adjudicated by an independent Clinical Events
Committee as not related to the device or the procedure.
Effectiveness of the Zilver Vascular Stent was confirmed by clinical and imaging assessment
post-procedure and at follow-up time points. Effectiveness measures included acute procedure
success, 30-day clinical success, ankle-brachial index, patency, and 9-month functional status
measured by the walking impairment questionnaire. These measures are summarized in Table 7.
Table 7: Effectiveness Measures for Patients Implanted with the Zilver Vascular Stent
Effectiveness
Measure
Acute Procedure
Success
30-day Clinical
Success
ABI
2
Patency of Stented
Lesion
Walking Distance
Score
Walking Speed
Score
1
One patient was excluded from the analysis due to placement of a non-study stent during the procedure.
2
There were 177 treated lesions in the study that occurred in 170 limbs.
N = number of limbs treated.
Pivotal Study Result
Point Estimate
16/151 (10.6%)
1
11/146 (7.5%)
2
Pre-Procedure Post-Procedure
0.68 ± 0.23
(N=154)
99.2% (123/124)
20.1 ± 28.8
(N=147)
25.6 ± 29.2
(N=141)
2-sided 95% CI
Upper Bound
16.6%
13.1%
One-Month
93.3%
(140/150)
1
94.0% (141/150)
0.88 ± 0.29 0.86 ± 0.20
(N=152)
63.5 ± 38.3
63.1 ± 37.4
12
OPC
Target Value Upper Limit
16%
Nine-Month
0.87 ± 0.21
(N=140) (N=137)
(105/113)
55.8 ± 40.1
(N=138) (N=124)
56.7 ± 37.5
(N=131) (N=119)
25%
92.9%