CraniSeal Post Approval Study

General Inclusion Criteria:

• Patient is ≥ 18 years of age
• Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that entails a dural incision
• Patient requires a procedure involving surgical wound classification Class I/Clean
• Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures.
• Patients who are able to comply with study requirements.

General Exclusion Criteria:

• Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/ or any procedure that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded
• Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
• Patient with diagnosis of severely altered renal (creatinine levels > 2.0 mg/dL) or hepatic (total bilirubin > 2.5 mg/dL) function
• Patient diagnosed with a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL)
• Patients undergoing cranial procedures involving petrous bone drilling
• Patients with traumatic injuries to the head or dural disease in planned dural closure area
• Patients who are pregnant or lactating
• Patient with an active infection
• Patient is undergoing cranial procedures involving non-autologous duraplasty material that are not collagen based
• Patients requiring re-opening of planned surgical area within 90 days after surgery.
• Patient with a known allergy to FD&C Blue #1 dye
• Patient is not able to tolerate multiple Valsalva maneuvers, or transient elevation of CSF pressure during Valsalva maneuvers is not possible (e.g. the presence of a temporary or permanent CSF shunt
• Presence of hydrocephalus
• Patient with a diagnosis of uncontrolled diabetes (e.g., persistent HbA1c elevation of >9% despite standard diabetes care),
• Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT>37 seconds or INR >1.5 units)
• Patient is not likely to comply with the follow-up evaluation schedule.
• Contraindications to both an MRI and CT scan.
• Patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy. (Observational studies on FDA approved products are not applicable)
• Patients diagnosed with Meningiomatosis (multiple meningiomas)