DuraGen® Secure matrix
Limit uncertainty with the enhanced contact assurance offered by DuraGen® Secure matrix.
As one of the pioneers in regenerative collagen medicine, Integra proposes Duraplasty Solutions™ for natural dural regeneration and CSF leakages prevention.
- Cellulose microlayer: The fluid activated cellulose microlayer associated with the conformability of DuraGen® Secure matrix allows to reinforce the contact at the dural margins.
- Resist sideways movement: The DuraGen® Secure matrix’s hydrostatic attraction offers at least 6 times more slip resistance than traditional collagen only grafts1.
- Stay in place: The DuraGen® Secure matrix’s hydrostatic attraction enables the graft to stay put at the dural margins even under repeated irrigation or prolonged immersion2.
- Compromised dural margins: DuraGen® Secure matrix helps to restore the contact during cases involving compromised dural margins.
1. Report #PDTR-114 Slip Testing for Collagen Only Products, page 5, 2012.
2. Functional Performance (Standing Fluid or Resistance to Migration under Irrigation) of DuraGen® Secure in a Canine Durectomy Model. NAMSA GLP Protocol #11171; CEP# T11-4615 Approved 17-November 2011.
DuraGen® Secure matrix is indicated as an only graft for the repair and restoration of dural defects in cranial and spinal surgical procedures. DuraGen® Secure matrix readily conforms to the surface of the brain, spinal cord and overlying tissues. DuraGen® Secure matrix may be used to close dural defects following traumatic injury, excision, retraction or shrinkage. DuraGen® Secure matrix may be used to supplement primary closure. DuraGen® Secure matrix 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 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.
DuraGen® Secure 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 repair of spinal neural tube defects or anterior spinal surgery with dural resection.
- 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.
|DRM1011I||1in x 1in (2.5 cm x 2.5 cm)||1/box|
|DRM1013I||1in x 3in (2.5 cm x 7.5 cm)||1/box|
|DRM1022I||2in x 2in (5 cm x 5 cm)||1/box|
|DRM1033I||3in x 3in (7.5 cm x 7.5 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 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. 0472248-1-EN
Document for use in Europe, Middle-East & Africa only.
For complete product information, please see the Instructions for Use accompanying each product.