Study to Evaluate Safety and Effectiveness of Spinal Sealant

Inclusion Criteria

• Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation.
• Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria)
• Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds.

Exclusion Criteria

• Active spinal and/or systemic infection
• Patient requires additional spinal surgery within the study time period
• Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure
• Patient has a pre-existing external lumbar CSF drain or internal CSF shunt
• Patient is participating in a clinical trial of another investigational device or drug
• Patient with creatinine > 2.0 mg/dL
• Patient with total bilirubin > 2.5 mg/dL
• Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation
• Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery
• Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or NSAIDS at the time of surgery
• Patient receiving warfarin or heparin at the time of surgery
• Patient has a diagnosed and documented compromised immune system and/or autoimmune disease
• Patient has has chemotherapy treatment within 6 months prior to, or planned during the study
• Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure
• Patient has known malignancy or other condition with prognosis shorter than 6 months
• Patients with documented history of uncontrolled diabetes
• Patient requires use of synthetic or non-autologous duraplasty material
• Patient has a gap greater than 2mm remaining after primary dural closure
• Patient has undergone laminoplasty decompression
• Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position
• Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level
• The investigator determines that participation in the study may jeopardize the safety or welfare of the patient
• The investigator determines that the patient should not be included in the study for reason(s) not already specified