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.
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. | 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 |
Product Catalogues
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Regulatory Information
Class IIa (accessories) and III
Integra Lifesciences Corporation
311 Enterprise Drive
Plainsboro • New Jersey 08536 • USA
Integra LifeSciences Services (France) SAS
Immeuble Sequoia 2 • 97 allée Alexandre Borodine
Parc technologique de la Porte des Alpes
69800 Saint Priest • FRANCE
Phone: +33 (0)4 37 47 59 00 • fax: +33 (0)4 37 47 59 99
emea.info@integralife.com
integralife.eu
Legal information
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.
• Please read carefully the instructions for use.
• Non contractual document. Integra reserves the right, without prior notice, to modify the products in order to improve their quality.
• Warning: Applicable laws restrict these products to sale by or on the order of a physician.
Additional information for EMEA Customers only: Products mentioned in this document are CE class IIa (accessories) and III devices. Please contact Integra customer service should you need any additional information on devices classification. All the medical devices mentioned on this document are CE marked according to European council directive 93/42/ EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.
DuraSeal and MicroMyst are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. All rights reserved.
Last modifcation date: 05/2016. 0472255-1-EN
Document for use in Europe, Middle-East & Africa only.
For complete product information, please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.
