Clinical Information - HyperBranch Adherus AutoSpray ET Dural Sealant NUS-009 Mode D'emploi

Table 1. Summary of Adherus AutoSpray Dural Sealant Adverse Events
Adverse Event
Anaemia
Leukocytosis
Deafness Unilateral
Tinnitus
Diplopia
Eyelid Ptosis
Periorbital Oedema
Vision Blurred
Dysphagia
Nausea
Adverse Reaction
Chest Pain
Disease Progression
Fatigue
Pneumonia
Urinary Tract Infection
Wound Infection
Incision Site Hypoaesthesia
Incision Site Pain
Periorbital Haemorrhage
Post Procedural Oedema
Pseudomeningocele
Seroma
Subdural Haematoma
Wound Dehiscence
Muscular Weakness
Aphasia
Balance Disorder
Convulsion
Cranial Nerve Palsies Multiple
Dizziness
Embolic Stroke
Headache
Hemiparesis
Hypoaesthesia
Hypoglossal Nerve Paralysis
Memory Impairment
Nystagmus
Paraesthesia
Sensory Loss
Tremor
VIIth Nerve Paralysis
Vocal Cord Paralysis
Atelectasis
Respiratory Failure
Alopecia
Rash
Swelling Face

Clinical Information

A prospective, randomized, controlled, multicenter pivotal trial has been conducted to evaluate the use of Adherus
Dural Sealant, delivered using the Adherus AutoSpray applicator, as an adjunct to standard methods of dural
repair, such as sutures, to provide watertight closure during cranial surgery. The primary endpoint of this study
was a composite evaluation of the safety and effectiveness of Adherus AutoSpray Dural Sealant (n=124 subjects)
when compared to an active control (n=126 subjects). The endpoint results were based on the number of subjects
who were free from intra-operative CSF leakage from dural repair after up to two applications of sealant during
the Valsalva maneuver, CSF leak/pseudomeningocele during the 120-day follow-up period and unplanned
Patients (n (%))
N=124
3 (2.4)
2 (1.6)
2 (1.6)
4 (3.2)
5 (4.0)
2 (1.6)
6 (4.8)
7 (5.6)
4 (3.2)
2 (1.6)
6 (4.8)
3 (2.4)
3 (2.4)
2 (1.6)
2 (1.6)
2 (1.6)
2 (1.6)
3 (2.4)
4 (3.2)
3 (2.4)
2 (1.6)
9 (7.3)
3 (2.4)
3 (2.4)
2 (1.6)
2 (1.6)
4 (3.2)
2 (1.6)
5 (4.0)
2 (1.6)
7 (5.6)
2 (1.6)
14 (11.3)
2 (1.6)
4 (3.2)
2 (1.6)
2 (1.6)
3 (2.4)
5 (4.0)
3 (2.4)
2 (1.6)
3 (2.4)
2 (1.6)
2 (1.6)
2 (1.6)
2 (1.6)
2 (1.6)
4 (3.2)
6