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 Sealant prevent CSF Leaks?
DuraSeal Dural Sealant 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 returns to a liquid form and is naturally absorbed by the body.

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In what surgical procedures can DuraSeal be used?
In the United States, DuraSeal is intended for use as an adjunct to sutured dural repair during cranial surgery. Like many absorbable hemostatic agents, DuraSeal has the potential to absorb fluid and increase dimensionally as much as 50% following implantation. Extensive pre-clinical and clinical evaluations have demonstrated that the modest increase in size of DuraSeal does not result in neural damage when used in craniotomies. The application of DuraSeal to confined bony structures where nerves are present is contraindicated.

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Is DuraSeal used to seal the dura in surgical procedures on patients with Chiari malformations?
Yes. In fact, patients with Chiari malformations were included in the pivotal IDE study. In the chiari patients, there was 100% success in achieving an intraoperative watertight seal of the suture lines and prevention of CSF leak. To learn more about Arnold Chiari Malformation and syringomyelia, please visit www.conquerchiari.org

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How effective is DuraSeal in sealing the dura?
DuraSeal was seen to be 98.7% effective in achieving watertight closure of the cranial dura in 2 clinical studies involving a total of 158 patients.

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How does DuraSeal compare to fibrin glues?

• DuraSeal 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 without fear of dislodgement.
• DuraSeal is easy to visualize with its blue color and has been shown to produce TRUE watertight closure in patients tested clinically.
• DuraSeal 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.
• DuraSeal is stored at room temperature and does not need refrigeration like fibrin glues.
• DuraSeal is the ONLY dural sealant approved for cranial use in the U.S.

*Data on file at Confluent Surgical

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What is DuraSeal’s safety profile?
The safety profile of DuraSeal has been established through extensive pre-clinical and clinical testing. Additional tests for neurotoxicity have also been performed showing an excellent safety profile. This data was used to support the approval of DuraSeal in the U.S., Europe, and Australia. DuraSeal is the ONLY dural sealant approved for cranial use in the U.S. Additional information may be obtained upon request from Confluent Surgical.

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What adverse events have been seen with clinical use of DuraSeal?
There have been no device related adverse events attributed to DuraSeal in clinical trials to date. There were also no unexpected adverse events noted in clinical testing. The adverse events seen were consistent with those expected in such neurosurgical procedures. For a complete list of adverse events, refer to the Instructions for Use.

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How is DuraSeal stored?
DuraSeal should be stored at room temperature in the hospital and does not need to be refrigerated.

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

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