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DuraSeal® Cranial Sealant System

Limit uncertainty by reinforcing watertightness at the dural closure stage thanks to DuraSeal® Cranial Sealant System.

The hydrogel technology of the DuraSeal® Family of products offers sealing solutions to reinforce CSF leakages prevention during dural repair procedures.

1027RX58475_Edited

Features:

  • Burst Strength1: DuraSeal® system offers features tissue adherence and cohesive strength to withstand critical CSF pressures during cranial procedures.
  • Biocompatibility2: DuraSeal® system is made from polyethylene glycol hydrogel (100% synthetic inert materiel).
  • Resorption: the DuraSeal® hydrogel is resorbed after 4 to 8 weeks, providing enough time for dura to heal adequately following application.
  • Blue colorant: provides visualization and allows to assess sealant coverage and thickness
  • Tight Spaces: the flexible and non-clogging applicators compatible with the DuraSeal® system allows to access to hard-to-reach areas of the brain.

1. Campbell P K. PhD. Et al. Evaluation of Absorbable Surgical Sealants: In vitro Testing LT-6000-016 Rev. A.; Confluent Surgical, Inc., Waltham, MA 02451, 2005, page 4
2. Table: ISO 10993 tests required for surgical sealants and list of tests carried out

Indications

  • The DuraSeal® Dural Sealant System is intended for use as an adjunct to standard methods of dural repair, such as sutures, to provide watertight closure.
  • The Extended Tip Applicator is intended for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.
  • The MicroMyst® Applicator is intended for use in the delivery of two non-homogenous solutions onto a surgical site.
  • The Flow Regulator is intended to provide pressurized gas (air or nitrogen) to gas-assisted applicators.

Contraindications

  • Do not apply the DuraSeal® Dural Sealant in abdominopelvic surgical procedures for use as a sealant or adhesion barrier.
  • Do not use Extended Tip Applicator, MicroMyst® Applicator and Flow Regulator for other indications than ones provided in the instructions for use.

Ordering Information

Catalog No.SizeQuantity
DSD5001DuraSeal® Cranial Sealant System 5mL1 kit/box
DSD5005DuraSeal® Cranial Sealant System 5mL5 kits/box
AccessoriesSizeQuantity
205108Extended Tip Applicator (8cm)Box of 5
205115Extended Tip Applicator (15cm)Box of 5
205000DSMicroMyst® Applicator (14cm) – For use with Flow RegulatorBox of 5
FR6065Flow Regulator – For use with MicroMyst® Applicator1 unit

Product Catalogues


Regulatory Information

For more information, please contact your Integra representative.
For complete product information, please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.