Study to Evaluate Safety and Effectiveness of Spinal Sealant

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