Suturable DuraGen® matrix
Limit uncertainty with the resistance to suturing offered by Suturable DuraGen® matrix.
As one of the pioneers in regenerative collagen medicine and thanks to its Ultra Pure Collagen™ technology, Integra proposes Duraplasty Solution™ for natural dural regeneration and CSF leakages prevention.
- Bilayer matrix: Suturable DuraGen® matrix combines the conformability of DuraGen® Plus matrix in addition to its suturability.
- Enhanced graft strength: Suturable DuraGen® matrix features an enhanced strength component (NeuraGen®) providing the graft the possibility of mechanical anchoring for challenging procedures.
Suturable DuraGen® is indicated as a dural substitute for the repair and restoration of dural defects in cranial and spinal surgical procedures. Suturable DuraGen® readily conforms to the surface of the brain and overlying tissues. Suturable DuraGen® may be used to close dural defects following traumatic injury, excision, retraction or shrinkage. Suturable DuraGen® may be used to supplement primary closure.
- Suturable DuraGen® may be used in the following procedures:
- Cranial Convexity: may be used to cover large defects following surgery, especially for dural loss from excision, contraction, retraction and/or shrinkage;
- Brain Swelling: intra-operative brain swelling or anticipated postoperative swelling;
- Posterior Fossa Surgery: 1) General use as a dural graft, 2) decompression craniectomy and dural release for infarcts, i.e., Posterior Inferior Cerebellar Artery (PICA) infarcts, 3) anticipated swelling after trauma, and 4) may be used in Chiari decompression procedures;
- Spinal Surgery: 1) General use as a spinal dural graft, especially useful for defects arising from pinhole tears, disc surgery, and spinal stenosis decompression, 2) after resection of intradural tumors, 3) Onlay graft after dural approximation with sutures, and 4) as a separation layer between the dura and overlying tissues.
Suturable DuraGen® is not designed, sold or intended for use except as described in the indications for use and is contraindicated in the following situations:
- For patients with a known history of hypersensitivity to bovine derived materials.
- Should be used with caution in infected regions.
|DURS1391ITL||1x3in - 2.5x7.5cm||box/1|
|DURS1395ITL||1x3in - 2.5x7.5cm||box/5|
|DURS2291ITL||2x2in - 5x5cm||box/1|
|DURS2295ITL||2x2in - 5x5cm||box/5|
|DURS3391ITL||3x3in - 7.5x7.5cm||box/1|
|DURS3395ITL||3x3in - 7.5x7.5cm||box/5|
|DURS4591ITL||4x5in - 10x12.5cm||box/1|
Regulatory and Legal Information
Integra LifeSciences Corporation
311 Enterprise Drive
Plainsboro, NJ 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
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 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”.
DuraGen is a registered trademark of Integra Lifesciences Corporation in the United States and/or other countries. Ultra Pure Collagen is a trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. All rights reserved.
Last modifcation date: 05/2016. 0472247-1-EN
Document for use in Europe, Middle-East & Africa only.
For complete product information, please see the Instructions for Use accompanying each product.