DuraGen Plus™ Adhesion Barrier Matrix
Limit uncertainty with…
DuraGen Plus™, enhanced performance and design for restoration of dural defects.
- Conforms like normal soft tissue, moulding easily to complex surfaces of the brain and spinal dura.
- New 12.5 cm x 17.5 cm size for use in large dural defects (e.g. decompressive hemicraniectomy).
- Engineered porosity (uniform pore structure) facilitates cell ingrowth.
- Increased tensile strength for superior handling.
DuraGen Plus™ inhibits fibrosis and prevents adhesion.
- The Adhesion Barrier Matrix provides a physical barrier between the dura and overlying tissues.
- The Adhesion Barrier Matrix remains in place during active healing and is fully resorbed after healing is complete.
- Simple sutureless technique that allows for precise placement in both spinal and cranial procedures.
DuraGen Plus™, the result of 30 years of innovation.
- Unmatched history of safety and effectiveness.
- Proven protection against CSF leakage with sutureless closure.
- No reported foreign body reactions or immune rejection.
- Integra’s Ultra Pure Collagen™ has been used by surgeons in over 10 million implant procedures.
- Integra’s Ultra Pure Collagen™ is used to manufacture products for some of the world’s largest medical device companies.
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
N/A (no product catalog available for DuraGen products)
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
DuraGen, Integra and the Integra logo are registered trademarks of Integra Lifesciences Corporation in the United States and/or other countries
For complete product information, please see the Instructions for Use accompanying each product.