ReDura RDS-2

Instructions for Surgical Implantation

1. Inspect the package carefully before use.
2. Tear or cut the outer package along the notch and take out the inner package by aseptic manipulation.
3. The aseptic inner package can be placed directly in sterilized environment.
4. Cover the product on the dural defect and fix it by a routine suturing. During suturing, pinholes should stay on the positions 2-3 mm away from the product patch edge. It is recommended that Regenerative Dural Repair Patch can be used together with water soluble glue, i.e. Fibrin glue, Duraseal glue, etc.
5. Alternatively, Regenerative Dural Repair Patch can also be used as an onlay graft by trimming it to a size permitting a minimum 15-20 mm overlap with the remaining dura. Stay sutures may be used if desired. For best results The Regenerative Dural Repair Patch should be used as described below:
   • Place the article into an appropriately sized container of warm saline.
   • Press onto the article with gloved fingers to ensure it absorbs the saline (2-5 minutes).
   • Remove the article from the saline once it becomes transparent to aseptically cut into appropriately sized and shaped sections.
   • Keep Regenerative Dural Repair Patch immersed in sterile saline until ready for use.
6. This product can be trimmed and cut as needed. The used product must be disposed as medical waste instead of being sterilized for reuse.
7. The user could close skull after being stitched up and make sure that there is no CSF leakage.
8. Mild folding does not affect the quality and performance of the product.
9. Do not use if package is damaged. The damaged packaging will destroy the sterile barrier of product.