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.
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 suturesto 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. | Size | Quantity |
|---|---|---|
| 203001 | DuraSeal® Xact Sealant System 3mL | 1 kit/box |
| 204003 | DuraSeal® Xact Sealant System 3mL | 5 kits/box |
| Accessories | Size | Quantity |
|---|---|---|
| 205108 | Extended Tip Applicator (8cm) | Box of 5 |
| 205115 | Extended Tip Applicator (15cm) | Box of 5 |
| 205000DS | MicroMyst® Applicator (14cm) – For use with Flow Regulator | Box of 5 |
| FR6065 | Flow Regulator – For use with MicroMyst® Applicator | 1 unit |