Seal to Heal with Duraseal
  • How does the DuraSeal® Dural Sealant System prevent CSF leaks?

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

    The DuraSeal Exact system has been developed to assist neurosurgeon and spine surgeons in obtaining a true watertight closure. Following normal dura suturing, the surgeon can spray DuraSeal Exact 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 dural healing is complete, the sealant returns to a liquid form and is naturally absorbed by the body in 9-12 weeks.
  • In what surgical procedures can DuraSeal dural sealant be used?

    In the United States, the DuraSeal sealant is intended for use as an adjunct to sutured dural repair during cranial surgery. Like many absorbable agents, DuraSeal sealant has the potential to absorb fluid and increase dimensionally as much as 50% following implantation. The application of DuraSeal confined bony structures where nerves are present is contraindicated.
  • In what surgical procedures can DuraSeal Exact spine sealant be used?

    The DuraSeal Exact Spine Sealant is intended for use as an adjunct to sutured dural repair during spinal surgery. The DuraSeal Exact Spine Sealant has the potential to absorb fluid and increase dimensionally as much as 12% following implanation. The application of DuraSeal Exact to confined bony structures where nerves are present is contraindicated.
  • How effective is the DuraSeal sealant in sealing the dura?

    In a clinical study conducted at Johns Hopkins, Drs. Than and Baird sought to evaluate the efficacy of DuraSeal cranial formulation in posterior fossa surgery in comparison with fibrin glue. They found that DuraSeal was four times more effective at preventing incisional CSF leaks than fibrin glue in posterior fossa surgery. Not only did DuraSeal result in fewer CSF Leaks, the authors also found DuraSeal’s watertight seal gave the dura more time to heal compared to fibrin glue. During the critical post-operative period, when most dural repair complications occur2, Than et al. found that patients treated with fibrin glue experienced CSF leak considerably sooner. Patients treated with fibrin glue also stayed in the hospital on average 1.3 days longer than those treated with DuraSeal.1
  • How effective is the DuraSeal Exact spine sealant in sealing the dura?

    In a prospective, multi-center, randomized, two arm, single blind study designed to assess whether DuraSeal Exact is more effective than Standard of Care methods for producing a watertight dural closure in subjects undergoing an intentional durotomy during spinal surgery, seventy-three of the 74 subjects (98.6%) randomized to DuraSeal Exact Spinal Sealant and 19 of the 24 subjects (79.2%) randomized to Standard of Care methods displayed a watertight closure after assigned treatment. The one subject within the DuraSeal Exact Spinal Sealant group that did not achieve success was not treated with DuraSeal Exact Spinal Sealant due to a deviation. DuraSeal Exact Spinal Sealant achieves 100% efficacy if the subject that was not treated with the spinal sealant is removed from the ITT analysis. For the Intent to Treat analysis, the difference in primary endpoint success rates was statistically significant with a p-value of 0.003; therefore, the success criterion for the study has been satisfied and the data demonstrate that the DuraSeal Exact Spinal Sealant is superior to the Standard of Care methods employed within the Control group for providing an intraoperative watertight closure following sutured dural repair.
  • What is the safety profile of DuraSeal and DuraSeal Exact sealants?

    The safety profile of DuraSeal sealants 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 the DuraSeal and DuraSeal Exact sealants in the U.S., Europe, and Australia. DuraSeal sealants are the ONLY dural sealants approved for cranial AND spinal use in the U.S. Additional information may be obtained upon request from Integra.
  • How are the DuraSeal and DuraSeal Exact sealants stored?

    DuraSeal and DuraSeal Exact sealants should be stored at room temperature in the hospital and does not need to be refrigerated. DuraSeal sealants are shipped under controlled temperature conditions to ensure they do not encounter high temperatures during shipping that could compromise their performance.
  • How are the DuraSeal and DuraSeal Exact sealants sterilized?

    DuraSeal and DuraSeal Exact sealants are terminally sterilized with radiation and shipped ready for use. DuraSeal and DuraSeal Exact sealants should not be re-sterilized.