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CraniSeal™
Dural Sealant
The Classic Choice
Achieve peace of mind and watertight closure with the CraniSeal Dural Sealant System.
CraniSeal helps achieve watertight closure during sutured dural repair
CraniSeal uses hydrogel technology to achieve watertight closure and reduce the risk of cerebrospinal fluid leak following sutured dural repair*
Product Features and Performance†
- Biocompatibility: Made from synthetic,
inert polyethylene glycol hydrogel - Burst Strength: Offers tissue adherence
and cohesive strength to withstand CSF
pressures after cranial procedures - Resorption: Resorbed after 4 to 8 weeks,
providing enough time for dura to heal
adequately following application - Blue Colorant: Provides visualization and
allows assessment of sealant coverage and
thickness
CraniSeal | DuraSeal®‡ | |
---|---|---|
Gel Time | 1.2 seconds | 1.3 seconds |
Percent Increase in Thickness due to Swelling at 24hrs | 32% | 36% |
Burst Pressure Testing | 284 cm of H2O | 215 cm of H2O |
Resorption | 45 days | 42 days |
Biocompatibility per ISO 10993 | Pass | Pass |
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Legal Section
*The CraniSeal Dural Sealant is indicated for use in patients ≥ 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. CraniSeal has been determined by the US FDA to be functionally the same as DuraSeal® Dural Sealant. Please refer to the Summary of Safety and Effectiveness Data (SSED) at www.fda.gov for CraniSeal.
†Data on file.
‡DuraSeal® is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
PRA-MKT-0003 Rev B
Pramand, LLC
201 Burlington Road
Bedford, MA 01730