Adherus Dural Sealant - Dressing, hydrogel

Intended purpose

Intended for use as an adjunct to standard methods of dural repair, such as sutures, during neurosurgical intervention to provide watertight closure and prevent cerebro spinal fluid (CSF)leakage which can lead to complications.

Functional description

Contains components for preparation of a synthetic surgical sealant and its assembly into a gas-assisted applicator. The PEG ester powder component A-1 is mixed with buffer A-2 to form a green solution. The PEI powder component B-1 is mixed with buffer B-2 to form a clear solution and the two solutions in their syringes are assembled with the applicator components. As the materials exit the applicator tip, they cross-link to form the hydrogel sealant which is absorbed in approx? 90 days.