What are CSF Leaks?
The brain and spinal cord are surrounded by a clear liquid called cerebral spinal fluid (CSF). Enclosing the brain, spinal cord and CSF is a tough, fibrous membrane called the dura mater. At the end of surgery, the dura is sutured closed, in an attempt to make it watertight and to prevent CSF from leaking. The leakage of CSF can create a potential pathway for infection inside the brain and spinal cord.

Surgeons often attempt to obtain a "watertight" closure when suturing the dura, but the dura may dry out during surgery and shrink, so that small gaps remain when it is sutured closed. Also, needle holes produced during suturing can leave small holes that may also leak. Despite meticulous attempts to close the dura, many patients experience symptoms resulting from CSF leakage after the surgery. These symptoms can include delayed healing of surrounding tissues since CSF is caustic to bone, muscle and skin. Collections of CSF under the skin can cause compression of nerves and breakdown of the wound closure. Low CSF levels can lead to severe headaches, which are aggravated by sitting or standing up. CSF leaks can also create a pathway to track bacteria and create life-threatening complications, such as meningitis.

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How does DuraSeal Xact Sealant prevent CSF Leaks?
DuraSeal Xact Sealant System has been developed to assist the surgeon in obtaining a true watertight closure. Following normal dura suturing, the surgeon can spray the sealant onto the incision, effectively sealing all the needle holes and other small gaps. The sealant then will stay in place, sealing the incision while healing occurs naturally underneath. Once dura healing is complete, in 4 to 8 weeks, DuraSeal Xact Sealant returns to a liquid form and is naturally absorbed by the body.

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In what surgical procedures can DuraSeal Xact be used?
DuraSeal Xact has a CE Mark for use in sealing dural tears to prevent CSF leaks in the lumbar spine for certain geographies outside the United States. Complete indications, contraindications, and warnings can be found in the product Instructions for Use (IFU).

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Is sealant expansion following implantation a concern in spine surgery?
Do not use DuraSeal Xact as a void filler in the spine, as post-operative hydrogel swelling may impinge on surrounding tissues. The hydrogel may swell up to 50% of it's size in any direction.

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Does DuraSeal Xact have adhesion prevention properties?
DuraSeal Xact does not have an indication as an adhesion barrier. However, due to the temporary mechanical properties of the hydrogel, DuraSeal Xact may serve as a mechanical barrier to separate adjacent tissues and may facilitate re-operation.

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How does DuraSeal Xact compare to fibrin glues?

• DuraSeal Xact Sealant has a higher tissue adherence strength and burst strength relative to fibrin glue* and reaches full strength within seconds. Suction and irrigation may be used in the vicinity of DuraSeal Xact Sealant without fear of dislodgement.
• DuraSeal Xact Sealant is easy to visualize with its blue color and has been shown to produce TRUE watertight closure in patients tested clinically.
• DuraSeal Xact Sealant is a completely synthetic material and unlike fibrin glue, does not have any human or animal blood components. Thus, there is no potential for viral transmission with DuraSeal Xact.
• DuraSeal Xact Sealant is stored at room temperature and does not need refrigeration like fibrin glues.

*Data on file at Confluent Surgical.

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How is DuraSeal Xact stored?
DuraSeal Xact should be stored at room temperature in the hospital and does not need to be refrigerated. DuraSeal Xact is shipped under controlled temperature conditions to ensure it does
not encounter high temperatures during shipping that could compromise its performance.

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How is DuraSeal Xact sterilized?
DuraSeal Xact is terminally sterilized with radiation and shipped ready for use.
DuraSeal Xact should not be re-sterilized.

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