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Cerebrospinal fluid leaks are a common complication in spine surgery and can lead to complications that affect quality of life to more serious ones associated with increased risk of patient morbidity.
DuraSeal® Exact Spinal Sealant is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.
Watch the below for a step-by-step guide to assembling the standard kit for DursaSeal® Exact Spine Sealant:
Watch the below surgical video to see DuraSeal® Exact Spine Sealant applied using the MicroMyst® Applicator after sutured dural closure:
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Do not apply the DuraSeal® Exact hydrogel to confined bony structures where nerves and spinal cord are present since neural compression may result due to hydrogel swelling. The hydrogel may swell up to 12% of its size in any dimension.
In the treatment arm of the DuraSeal® Exact PMA clinical study the rate of post-operative CSF leaks in Chiari malformation procedures was reported as 30.4% (7/23). Of the 30.4%, 8.7% are CSF Fistula, 8.7% are Pseudomeningocele (surgical intervention required), and 13% are Pseudomeningocele (no surgical intervention required).
In the PMA study of 98 randomized subjects, the overall incidence of protocol defined CSF leaks within 90 days post-procedure was slightly lower in the DuraSeal® Exact arm, but not statistically different within the two groups: DuraSeal® Exact 11.0% vs. Control 12.5%. There were no statistically significant differences between treatments in the incidence of AEs and SAEs between the two treatment groups.
Please see DuraSeal® Exact Instructions for Use for more information