Device Dossier

Immiseal™ Dural Sealant System - Dura mater sealant

Device Dossier for Immiseal™ Dural Sealant System - Dura mater sealant (Dura mater sealant, Class III, sponsor Life Healthcare). ARTG record, intended…

Intended purpose

Immiseal™ Dural Sealant System is indicated for use as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures.

Functional description

This device consists of a surgical sealant that rapidly polymerizes in situ to form a hydrogel. The hydrogel is made up of two solutions, a polyethylene glycol (PEG) ester solution and a mixed solution of ɛ-polylysine and polyethyleneimine (PEI). The sealant is applied to the target site via an auxiliary delivery system comprising an applicator and a spray tip and/or long tip.

TGA Public Summary