Researchers examine the benefits of TMR vs. traditional amputation in a large, randomized trial.
It’s estimated that there are 3 million non-fatal trauma injuries each year in the U.S., whether from motor vehicle accidents, lacerations, penetrating trauma, stretching or crushing trauma or fractures. While roughly 1.64% of trauma patients will suffer a peripheral nerve injury, such deficits may have an immense impact on the quality of life and ability to work for these patients.
What’s more, peripheral nerve regeneration is typically slow and incomplete, depending on the extent of the transection injury, even with recent advances in microsurgical repair.
Nerve autografting is often considered the gold standard of care for peripheral nerve injury, but it is only available in a limited supply and comes with the potential for donor site morbidity and neuroma pain.
That’s where nerve conduits come in. And when it comes to conduits, material matters.
Made from a bovine Type I collagen outer conduit with a porous inner matrix comprised of collagen and glycosaminoglycan (GAG), NeuraGen® 3D Nerve Guide Matrix is an innovative solution in the conduit market. It is specifically engineered to provide an optimized environment that may allow for more complete functional recovery of mid-gap nerve repairs, defined as discontinuities between 1-2 cm.9
Here are five things you need to know about NeuraGen®3D:
- NeuraGen® 3D Nerve Guide Matrix is specifically intended for mid-gap nerve repair, nerve discontinuities between 1 and 2 cm.
- NeuraGen® 3D Nerve Guide Matrix uses the same outer structure that surgeons are familiar with. This includes the semi-permeable membrane along with the engineered architecture of NeuraGen® Nerve Guide.1
- It features an inner collagen matrix infused with Chondroitin-6-Sulfate that has preclinically demonstrated to be longitudinally aligned to help guide Schwann cell in-growth and axonal regeneration.4 This matrix is derived from bovine Type I collagen, which has a pore size and longitudinal array that has shown preclinically to closely mimic Schwann cell basal lamina.3 Schwann cells perform a vital role in nerve regeneration by forming pathways that guide regenerating axons along the repair site.5
- The outer collagen structure allows for diffusion of smaller, nutrient molecules.1,4 It also isolates and protects the peripheral nerve as axons regenerate and retains larger molecules such as nerve growth factor.
- It’s made of Integra’s Ultra Pure Collagen™ (Type I Bovine Collagen), which has shown preclinically to help maximize tissue compatibility. For more than 30 years and over ten million implantations, Integra has been developing and manufacturing high quality collagen implants for a number of clinical applications including general surgery, burn surgery, neurosurgery, plastic and reconstructive surgery, oral surgery, and peripheral nerve/tendon surgery. Ultra Pure Collagen™ was designed to limit the risk of foreign body reaction, reduce the chance of encapsulation by fibrous tissue, and mitigate the possibility of immunological response.5-8
INDICATIONS FOR USE
NeuraGen 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
NeuraGen 3D Nerve Guide Matrix is not designed, sold, or intended for use except as described in the indications for use and is contraindicated for patients with a known history of hypersensitivity to bovine-derived or chondroitin materials.
Do not re-sterilize
Do not use if the product package is damaged or opened
Hemostasis of the nerve stumps must be achieved prior to placement of the NeuraGen 3D Nerve Guide Matrix. A blood clot in the lumen of the nerve guide will impede axon growth.
Tensionless repair technique should be used to prevent tension along the length of the nerve.
NeuraGen 3D Nerve Guide Matrix should be used with caution within infected regions.
Data on file at Integra LifeSciences Corporation CP-08-026: Characterization Report assessing NeuraGen 3D permeability to glucose, myoglobin and bovine serum albumin
Shakhbazau A, Archibald SJ, Shcharbin D, Bryszewska M, Midha R. Aligned collagen-GAG matrix as a 3D substrate for Schwann cell migration and dendrimer-based gene delivery. J Mater Sci Mater Med.2014;25(8): 1979-1989.
Shakhbazau, A, et al. Aligned Collagen-GAG Matrix as a 3D Substrate for Schwann Cell Migration and Dendrimer-Based Gene Delivery. Journal of Materials Science: Materials in Medicine, vol. 25, no 8, July 2014, pp 1979-1989.
Lee, JY, et al. The Effect of Collagen Nerve Conduits Filled with Collagen-Glycosaminoglycan Matrix on Peripheral Motor Nerve Regeneration in a Rat Model. Journal of Bone and Joint Surgery, vol. 94-A, no. 22, November 2012, pp 2084-2091.
Lynn AK, Yannas IV, Bonfield W. Antigenicity and Immunogenicity of Collagen. J Biomed Mater Res Part B: Appl Biomater 71B: 343-354, 2004.
AT Collagen Purity by TCA Precipitation, Report #: CRC-091701 25.
Hydroxyproline Content in AT Collagen, Report # CRC-091401, Rev-0, Issue Date: September 14, 2001.
Li ST, Archibald SJ, Krarup C, Madison RD. Peripheral nerve repair with collagen conduits. Clin Mater. 1992;9(3-4):195-200. doi: 10.1016/0267-6605(92)90100-8. PMID: 10149970.
Data on file at Integra LifeSciences Corporation: 18-0447 MarketVision NeuraGen3D Exploratory Research June 2018.