DuraSeal Sealant Post Market Study

DuraSeal Sealant Post Market Study

DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).

Inclusion Criteria:

• Patient is between 18 and 75 years of age
• Patient is scheduled for an elective cranial procedure that entails a dural incision
• Evidence of intraoperative non-watertight closure