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.

DuraSeal® Xact is engineered for minimal swelling*and appropriate strength for the tighter confines and higher pressures of the spine

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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
*DuraSeal® Xact may swell up to 12% in any one dimension.

Intended Use

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

Regulatory and Legal information

INTEGRA LifeSciences Corporation
1100 Campus Road,
Princeton, New Jersey 08540 • 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


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.

  • Non contractual document. The manufacturer 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.
  • Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

Products mentioned in this document are CE class IIa (Extended Tip Applicators) 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 in accordance with the applicable European laws, 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 modification date: 09/2022. 0472255-2-EN
Document for use in Europe, Middle-East & Africa only.

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.