Device Dossier
Adherus AutoSpray - Dura mater sealant
Device Dossier for Adherus AutoSpray - Dura mater sealant (Dura mater sealant, Class III, sponsor Stryker). ARTG record, intended purpose, GMDN category…
- GMDN category: Dura mater sealant
- Sponsor: Stryker
Intended purpose
Adherus AutoSpray is intended for use as an adjunct to standard methods of dural repair, such as sutures,to provide watertight closure during cranial and spinal procedures.
Functional description
Adherus AutoSpray is a sterile, single-use, electromechanical, battery operated, device to aid in the delivery of a synthetic, absorbable, two-component hydrogel sealant system. It is supplied as a pre-assembled applicator with 2 vials. One vial contains activated polyethylene glycol (PEG) ester powder while the other polyethyleneimine (PEI) dissolved in sterile water.The solutions mix within the applicator & crosslink to form the hydrogel sealant soon after exiting the applicator tip.