DuraSeal Exact Spine Sealant System Post-Approval Study
DuraSeal Exact Spine Sealant System Post-Approval Study
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
Inclusion Criteria:
Subject is 18 years of age or older
Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:
Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.
Exclusion Criteria: