HyperBranch Adherus AutoSpray ET Dural Sealant NUS-009 Mode D'emploi page 8

Subject had uncontrolled diabetes as evidenced by the Institution's standard of care (HbA1c >7%, blood
glucose, etc) at baseline.
Intra-Operative Inclusion Criteria:
Subject's linear extent of durotomy was ≥ 2 cm.
Subject's dural margins from the edges of bony defect were ≥ 3 mm throughout.
Subject's CSF leak was present intra-operatively following completion of primary dural closure (with or
without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva
maneuver, at up to 20 cm H
Intra-Operative Exclusion Criteria:
Subject had an Incidental finding that met any pre-operative exclusion criterion listed above.
Subject required the intra-operative placement of a CSF diversion device (e.g. ventricular catheter,
subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that was left in
place after the procedure. Note: Subgaleal drains used for acute post-operative management of the
incision site were permitted.
Subject had a gap > 2 mm present between dural edges, or between the edge of dura and duraplasty
material, based on visual estimate by surgeon before application of the surgical sealant.
Table 2. Summary of Demographic Information for Study Patients
Characteristics
Number of Subjects
Men/Women
Median Age (years)
Subject ASA score (N (%))
I
II
III
IV
V
Primary indication for surgery (N (%))
Tumor
Epilepsy
Nerve decompression
AVM
Aneurysm
Chiari malformation
Cyst
Other
Approach (N (%))
Infratentorial
Supratentorial
Primary technique for dural closure (N (%))
Suture
Suture + autologous dural material
Suture + non-autologous dural material
AEs reported at a rate of great than 1% in the intent to treat (ITT) subject population are summarized in Table 1,
above.
O for up to five (5) seconds.
2
8
Adherus AutoSpray
Dural Sealant
Population Control Population
124
41/83
54.2
2 (1.6)
47 (37.9)
69 (55.6)
6 (4.8)
0 (0.0)
56 (45.2)
1 (0.8)
17 (13.7)
3 (2.4)
28 (22.6)
17 (13.7)
2 (1.6)
0 (0.0)
53 (42.7)
71 (57.3)
48 (38.7)
29 (23.4)
45 (36.3)
126
40/86
51.1
8 (6.3)
50 (39.7)
62 (49.2)
6 (4.8)
0 (0.0)
53 (42.1)
1 (0.8)
21 (16.7)
5 (4.0)
26 (21.3)
18 (14.3)
1 (0.8)
1 (0.8)
52 (41.3)
74 (58.7)
48 (38.1)
34 (27.0)
39 (31.0)