DuraGen® Plus matrix
Limit uncertainty with the performance of the conformability offered by DuraGen® Plus 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.
- Onlay graft: DuraGen® Plus matrix allows the graft to be used without sutures thanks to surface tension alone.
- Conformability: DuraGen® Plus matrix conforms intimately with the complex surfaces of the brain and/or spinal cord.
- Handling: the 30% increased in tensile strenght* allows DuraGen® Plus matrix to offer an easier handling during placement or repositionning.
- Dedicated larger size: large graft of 12.5×17.5cm available for trauma cases and/or decompressive hemicraniectomies.
- Adhesion Barrier: To inhibit post-surgical peridural fibrosis in procedures where nerve roots are exposed.
*vs. DuraGen® matrix, the 1st generation of Integra dural grafts.
DuraGen® Plus Adhesion Barrier Matrix is indicated as an Onlay graft for the repair and restoration of dural defects in cranial and spinal surgical procedures. DuraGen® Plus matrix is also indicated as an adhesion barrier for the inhibition of post-surgical peridural fibrosis. DuraGen® Plus matrix readily conforms to the surface of the brain, spinal cord and overlying tissues. DuraGen® Plus matrix may be used to close dural defects following traumatic injury, excision, retraction or shrinkage. DuraGen® Plus matrix may be used to supplement primary closure. In clinical evaluations, DuraGen® Plus matrix has been demonstrated to be an effective dural graft matrix for 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 Onlay 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,
4) as a separation layer between the dura and overlying tissues;
- Adhesion Barrier: To inhibit post-surgical peridural fibrosis in laminectomy, laminotomy or discectomy procedures where nerve roots are exposed.
DuraGen® Plus matrix 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.
- For primary repair of spinal neural tube defects; anterior spinal surgery with dural resection (e.g., transoral surgery).
- Should be used with caution in infected regions.
- Not recommended to cover dural defects involving mastoid air cells.
- Not recommended for large defects at the skull base following surgery.
|DP1011l||1 in x 1 in (2.5 cm x 2.5 cm)||1/box|
|DP5011l||1 in x 1 in (2.5 cm x 2.5 cm)||5/box|
|DP1013l||1 in x 3 in (2.5 cm x 7.5 cm)||1/box|
|DP5013l||1 in x 3 in (2.5 cm x 7.5 cm)||5/box|
|DP1022l||2 in x 2 in (5 cm x 5 cm)||1/box|
|DP5022l||2 in x 2 in (5 cm x 5 cm)||5/box|
|DP1033l||3 in x 3 in (7.5 cm x 7.5 cm)||1/box|
|DP5033l||3 in x 3 in (7.5 cm x 7.5 cm)||5/box|
|DP1045l||4 in x 5 in (10 cm x 12.5 cm)||1/box|
|DP1057l||5 in x 7 in (12.5 cm x 17.5 cm)||1/box|
Regulatory and Legal Information
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
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 or its subsidiaries in the USA 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.
©2016 Integra LifeSciences Corporation. All rights reserved.
Last modifcation date: 05/2016. 0472241-1-EN
Document for use in Europe, Middle-East & Africa only
For complete product information, please see the Instructions for Use accompanying each product.