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DuraGen Plus® Dural Regeneration Matrix


Integra’s most optimized dural graft

DuraGen Plus

  • More consistent collagen structure over Integra DuraGen® Dural Graft Matrix for superior handling
  • Provides a simple technique for precise placement of the matrix between the dura and overlying tissues in cranial and spinal procedures
  • Handles like normal soft tissue, easily conforming to the complex surfaces of exposed neural tissue
  • Effective protection against cerebrospinal fluid (CSF) leakage with sutureless closure
  • Fully resorbed and replaced by native tissue with complete dural closure
  • Suturing is not required, but tensionless stay sutures may be used if desired


Integra Duraplasty Solutions™ Product Attributes

AttributesBenefit
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 PorosityHas 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 DuraGen Plus® Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.


Contraindications:
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:

  • For patients with a known history of hypersensitivity to bovine derived materials.
  • For 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.


Warnings:

  • Do Not Resterilize!
  • Do not use if the product package is damaged or opened.
  • Integra DuraGen Plus Matrix is generally not recommended for extensive skull base surgery with dural resection, however, DuraGen Plus Matrix can be used to augment other forms of specific repair (i.e., Fascia lata).



Precautions:

  • Rinse surgical gloves to remove any glove powder prior to handling Integra DuraGen Plus Matrix.
  • If Integra DuraGen Plus Matrix is to be sutured, tensionless suturing technique must be used to prevent tearing the DuraGen Plus Dural Regeneration Matrix.
  • Integra DuraGen Plus Dural Regeneration Matrix should be cut to size ensuring an overlap to cover the existing dura.


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 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.




For complete product information, please see the Instructions for Use accompanying each product.
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