Integra’s reinforced dural graft
- Versatile graft that can be sutured or used as an onlay
- Designed for repairing dural defects where mechanical anchoring of the graft is preferred
- Excellent suture retention while maintaining the biological activity of DuraGen Plus® Matrix
- Handles like normal soft tissue, easily conforming to the complex surfaces of exposed neural tissue
- Demonstrates effective protection against cerebrospinal fluid (CSF) leakage with sutureless closure
- Fully resorbed and replaced by native tissue with complete dural closure
Integra Duraplasty Solutions™ Product Attributes
| Attributes | Benefit |
| Ultra Pure Collagen™ | Limits uncertainty: no reported foreign body reactions or graft rejections in over 750,000 patients |
| Fibrin Clot Formation | Provides the structure for initial fibrin clot formation to prevent CSF leakage |
| Excellent Conformability | Ensures graft approximation at the dural margin to protect against CSF leakage |
| Engineered Porosity | Has an optimized pore structure to ensure consistent matrix hydration and uniform tissue repair throughout the dural graft |
| Optimized Resorption | Matrix resorbs at a similar rate that new tissue forms to prevent encapsulation |
Integra's Ultra Pure Collagen™ for Duraplasty
Integra manufactures the DuraGen family of products from Ultra Pure Collagen which is sourced from Bovine Achilles Tendon. This Type I collagen has been manufactured and purified to:
- Limit the risk of foreign body reaction
- Reduce the chance of encapsulation by fibrous tissue formation
- Mitigate the possibility of immunological response
Integra's Duraplasty Solutions™ have been implanted in over 750,000 patients and are used in neurosurgical procedures worldwide. Clinical studies have shown minimal adhesion formation, effective protection against CSF leakage with sutureless closure, and no reports of foreign body reactions or immune rejections.
Indication:
Integra Suturable DuraGen™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Contraindications:
Integra Suturable DuraGen 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.
- Should be used with caution in infected regions.
Warnings:
- Do Not Resterilize!
- Do not use if the product package is damaged or opened.
- Integra Suturable DuraGen Matrix should be used with caution for extensive skull base surgery with dural resection. Integra Suturable DuraGen Matrix can be used to augment other forms of specific repair (i.e., Fascia lata).
- Integra Suturable DuraGen Matrix should be used with caution for posterior fossa procedures (e.g., transoral surgery).
- Use caution in repair of spinal neural tube defects or anterior spinal surgery with dural resection (e.g., Chiari Malformations).
- Use caution when covering dural defects involving mastoid air cells.
Precautions:
- Rinse surgical gloves to remove any glove powder prior to handling Integra Suturable DuraGen Matrix
- When applied using an onlay technique or a suture technique, Integra Suturable DuraGen Matrix should be cut generously to ensure that the graft overlaps the existing dura at the margin of the defect.
Adverse Events:
Possible complications can occur with any neurosurgical procedure and include cerebrospinal fluid leaks, infection, delayed hemorrhage and adhesion formation. In clinical evaluations involving 1096 patients, postoperative wound infection rates for porous collagen matrix were reported at approximately the same rate as the control group. Postoperative cerebrospinal fluid leaks were reported in 3 of 67 patients who underwent intradural posterior fossa procedures. Macroscopic evaluations revealed minimal adhesion formation only when there was significant disruption of the pia-arachnoid. There were no reports of graft encapsulation, neomembrane formation or foreign body reactions. There were no reports of graft rejection at histology