English:US Search You are here: Home » Products » For the Neurosurgeon » Duraplasty » DuraSeal® Xact Spinal Sealant System For the Burn and Wound Surgeon For the Extremity Reconstruction Surgeon For the Liver Surgeon For the Neurosurgeon Brain Mapping Cranial Stabilization CSF Management Duraplasty DuraGen Plus™ Adhesion Barrier Matrix DuraGen® Plus matrix DuraGen® Secure matrix DuraSeal® Cranial Sealant System DuraSeal® Xact Spinal Sealant System Suturable DuraGen® matrix Electrosurgery NeuroCritical Care Stereotaxy Tissue Ablation Instruments Surgical Instruments Customer Portal 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. 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 – 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 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. Message for healthcare professionals working in France only / Message à destination des professionnels de santé exerçant en France: Ce site n'est pas en accord avec la loi Bertrand; les pages produits ne vous sont pas adressées. Pour tout renseignement sur la société Integra et la loi Bertrand, veuillez consulter la page bienvenue. © Copyright 2010-2018 Integra LifeSciences Corporation. All rights reserved. | Terms of use | Privacy policy | Sitemap integralife.eu cookie policy We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We also share information about your use of our site with our social media, advertising and analytics partners. Accept Cookies Cookie Settings