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DuraGen Plus® Dural Regeneration Matrix
Integra’s most optimized dural graft
Integra Duraplasty Solutions™ Product Attributes
|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:
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.
Integra DuraGen Plus® Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Integra 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:
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 Integra's Dural Regeneration 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.