COOK Medical Zenith Flex, Instructions For Use Manual

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Fig. 6.4.2 presents AAA-related survival (determined by Clinical Events Committee) to 24 months. The accompanying table presents the Kaplan-Meier analysis
at 1, 6, 12 and 24 months.
Fig. 6.4.2 AAA-Related Survival at 24 Months
Zenith Standard Risk
(N=200, 1 death to 30 days
1 death to 6 months
1 death to 12 months
2 deaths to 24 months)
Surgical Standard Risk
(N=80, 2 deaths to 30 days
3 deaths to 6 months
3 deaths to 12 months)
Per
cen
t F
reedom fr
om
A
neur
ysm Rela
ted Dea
th
Months After Procedure
Event: Aneurysm Related Death
1 month 6 months 12 months 24 months
n % survival n % survival n % survival n % survival
Zenith standard risk 198* 99.5 194 99.5 190 99.5 97 99.0
Surgical standard risk 78 97.5 73 96.2 67 96.2 n/a n/a
n = Patients alive and available for follow-up at the end of the interval
P = .04
*One patient expired before 1 month and one patient did not receive a device.
Table 6.4.3 Success Measures
Item Zenith Standard Risk Surgical Standard Risk Zenith High Risk Zenith Roll-in
Technical success 1 99.5% (199/200) 98.8% (79/80) 100% (100/100) 100% (52/52)
Procedural success at 30 days
2
95.1% (155/163) 88% (60/68) 86% (70/81) 91% (30/33)
Treatment success at 12 months 3 89% (122/137) 85% (52/61) 70% (44/63) 87% (26/30)
1 Patent graft following deployment.
2 Technical success with no major complications, patent graft and no Type I or Type III endoleaks at 30 days.
3
Procedural success extended to 12 months with no aneurysm enlargement (>5 mm).
Fig. 6.4.3 presents freedom from morbidity (events in the morbidity index) to 12 months. The accompanying table presents the Kaplan-Meier analysis at 1, 6
and 12 months.
Fig. 6.4.3 Freedom from Morbidity (0-365 days)
Zenith Standard Risk
(N=200, 38 patients with events to 30 days
43 patients with events to 6 months
45 patients with events to 12 months)
Surgical Standard Risk
(N=80, 34 patients with events to 30 days
38 patients with events to 6 months
41 patients with events to 12 months)
Per
cen
t F
reedom fr
om Morbidit
y
Months After Procedure
1 month 6 months 12 months
n % n % n %
Zenith standard risk 162 81.0 154 78.5 133 77.4
Surgical standard risk 45 57.1 39 52.0 33 47.8
n = Patients alive and free of morbidity at the end of the interval
P = <.001
Tables 6.4.4 through 6.4.7 describe results of the Zenith AAA Endovascular Graft subjects as reported by the Core Lab. Device performance factors analyzed by
the Core Lab include device integrity (Table 6.4.4), device patency (Table 6.4.5), migration (Table 6.4.6) and limb separation (Table 6.4.7).
Table 6.4.4 Abdominal Radiographic Findings – Device Integrity
Item Zenith Standard Risk Zenith High Risk Zenith Roll-in
Stent Fractures 1
0.0% (0/172) 0.0% (0/81) 0.0% (0/39) Pre-discharge
30 day
0.0% (0/172) 0.0% (0/83) 0.0% (0/43)
6 month 0.0% (0/166) 0.0% (0/78) 0.0% (0/35)
12 month 0.0% (0/148) 0.0% (0/60) 0.0% (0/28)
24 month 0.0% (0/93) 0.0% (0/42) 0.0% (0/19)
Barb Separation 2
0.0% (0/176) 0.0% (0/86) 0.0% (0/39) Pre-discharge
30 day
0.0% (0/178) 0.0% (0/86) 0.0% (0/43)
6 month 1.2% (2/167) 2.5% (2/80) 0.0% (0/35)
12 month 2.0% (3/149) 1.7% (1/60) 0.0% (0/28)
24 month 1.1% (1/93) 0.0% (0/42) 0.0% (0/19)
Graft material rupture
0.0% (0/176) 0.0% (0/86) 0.0% (0/39) Pre-discharge
30 day
0.0% (0/178) 0.0% (0/86) 0.0% (0/43)
6 month 0.0% (0/167) 0.0% (0/80) 0.0% (0/35)
12 month 0.0% (0/149) 0.0% (0/60) 0.0% (0/28)
24 month 0.0% (0/93) 0.0% (0/42) 0.0% (0/19)
1 Stent fracture percentages are for main body. There were also no right iliac leg, left iliac leg, occluder, converter, left iliac extension, right iliac extension or
main body extension fractures observed by the Core Lab.
2
Patients with separation of 1 or 2 barbs (of 10 or 12 total); no adverse clinical sequelae.