topBanner_DuraSealXactSealantSystem
Integra News
Integra Events
Transparence

Loi Bertrand
Professionnels de santé exerçant en France, veuillez consulter la page Bienvenue.

DuraSeal® Xact Spinal Sealant System

Limit uncertainty by reinforcing watertightness at the dural closure stage thanks to DuraSeal® Xact Spinal 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® Xact system offers features tissue adherence and cohesive strength to withstand critical CSF pressures during spinal procedures.
  • Biocompatibility2: DuraSeal® Xact system is made from polyethylene glycol hydrogel (100% synthetic inert materiel).
  • Resorption: the DuraSeal® Xact hydrogel is resorbed after 9 to 12 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® Xact system allows to access to hard-to-reach areas of the spine.

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® Xact System is indicated for use during spine procedures 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® Xact hydrogel 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
203001DuraSeal® Xact Sealant System 3mL1 kit/box
204003DuraSeal® Xact Sealant System 3mL5 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 and Legal Information

For more information, please contact your Integra representative.
For complete product information, please see the Instructions for Use accompanying each product.