A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.

"Following are the general instructions for use for the ArtiFascia®:~* Cut the ArtiFascia® to the required shape under aseptic conditions~* Apply ArtiFascia® to the damaged area~* Suture the ArtiFascia® in place~* Suture bites should be taken 2-3 millimeters from the edges of the implant. Either a running suture or interrupted stitches' technique may be used, depending on clinical conditions or surgeon's decision.~Important Note: If clinically possible, do not use dural adhesive or sealants as it is an uncontrolled variable, that can influence the results."

Implantation of the commercial suturable dural substitute will be according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Detailed instructions are in the instructions for use