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.

Overview

The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery. Subjects with planned cranial neurosurgery participated in this study. During the surgery the dura is likely to be cut and damaged. A damaged dura can cause a leakage of brain fluids (cerebrospinal fluid \[CSF\] leakage) and increase the risk of infections. The damaged dura can be fixed with dural patch like ArtiFascia®. ArtiFascia® is a bioabsorbable medical synthetic dural replacement that aids in the regeneration of a new dura. Furthermore, it incorporates a sealing layer capable of minimizing CSF leakage and infection.

A Prospective, randomized, controlled multi-center study of ArtiFascia® Dural repair patch compared with commercially available dural substitutes- NEOART Study. The dura mater is a fibrous connective tissue that surrounds the nervous system (brain and spinal cord) and provides a mechanical barrier that contains the cerebrospinal fluid (CSF). The dura mater may be damaged as a result of trauma or planned surgery. When dural defects cannot be repaired by primary closure, a dural substitute must be utilized in order to reduce CSF leakage. There are devices that have been used as dural substitutes. Among the devices that are based on natural raw materials, collagen-based matrices are widely used. Although collagen was proven to be biocompatible, using collagen-based materials still possess several limitations such as CSF leaks. Synthetic dural substitutes are also used to repair dura mater. The most widely used raw-material for these synthetic products are polyesters - resorbable and biocompatible polymers. There are several dural substitutes based on synthetic polyesters that were successfully tested pre-clinically as well as in human studies. Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a polymeric synthetic dural substitute that is absorbed by the body. Before the study, all subjects underwent neurological assessment. Only subjects that were found to be suitable to participate in the study, and agree to participate, were randomly allocated into one of the following groups: * Experimental group (ArtiFascia® device); * Control group (Other commercially available suturable dural substitutes). The Sponsor was blinded to treatment. The subjects underwent the planned surgery and at the end the investigator used ArtiFascia® patch or standard dural substitute to repair the damaged Dura. ArtiFascia® graft was placed in areas where the native dural layer was damaged or missing. ArtiFascia® was applied via a routine and well-known procedure, using a suturing technique. After implantation, the porous fibrous structure of ArtiFascia® provides a scaffold, which enables infiltration of fibroblasts and cells from the intact tissue, ultimately replacing damaged dural tissue. The patch is expected to resorb within a few months and to be replaced by the native tissue with complete dural closure. During the surgery and until subject's release from the hospital the subject's health was closely monitored. Before the discharge subjects underwent neurological examination. Subjects had been followed up at 4-6 weeks and at 6 months post surgery. At each follow up visit physical and neurological examinations were performed. Radiographic Evaluation (Magnetic Resonance Imaging) was performed at 6 months post operation. A total of 92 subjects from 7 sites in Europe were enrolled and implanted with test or control device. The primary endpoint was achieved when the final study subject has completed a 6-months follow-up.