6
Table 1. Summary of Adherus AutoSpray Dural Sealant Adverse Events
Adverse Event
Patients (n (%))
N=124
Anaemia
3 (2.4)
Leukocytosis
2 (1.6)
Deafness Unilateral
2 (1.6)
Tinnitus
4 (3.2)
Diplopia
5 (4.0)
Eyelid Ptosis
2 (1.6)
Periorbital Oedema
6 (4.8)
Vision Blurred
7 (5.6)
Dysphagia
4 (3.2)
Nausea
2 (1.6)
Adverse Reaction
6 (4.8)
Chest Pain
3 (2.4)
Disease Progression
3 (2.4)
Fatigue
2 (1.6)
Pneumonia
2 (1.6)
Urinary Tract Infection
2 (1.6)
Wound Infection
2 (1.6)
Incision Site Hypoaesthesia
3 (2.4)
Incision Site Pain
4 (3.2)
Periorbital Haemorrhage
3 (2.4)
Post Procedural Oedema
2 (1.6)
Pseudomeningocele
9 (7.3)
Seroma
3 (2.4)
Subdural Haematoma
3 (2.4)
Wound Dehiscence
2 (1.6)
Muscular Weakness
2 (1.6)
Aphasia
4 (3.2)
Balance Disorder
2 (1.6)
Convulsion
5 (4.0)
Cranial Nerve Palsies Multiple
2 (1.6)
Dizziness
7 (5.6)
Embolic Stroke
2 (1.6)
Headache
14 (11.3)
Hemiparesis
2 (1.6)
Hypoaesthesia
4 (3.2)
Hypoglossal Nerve Paralysis
2 (1.6)
Memory Impairment
2 (1.6)
Nystagmus
3 (2.4)
Paraesthesia
5 (4.0)
Sensory Loss
3 (2.4)
Tremor
2 (1.6)
VIIth Nerve Paralysis
3 (2.4)
Vocal Cord Paralysis
2 (1.6)
Atelectasis
2 (1.6)
Respiratory Failure
2 (1.6)
Alopecia
2 (1.6)
Rash
2 (1.6)
Swelling Face
4 (3.2)
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
