Nexeon® Decellularized Femoral Artery

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Instructions for Use
Product Specifications

Nexeon®
Decellularized Femoral Artery

Nexeon is a decellularized vascular allograft intended for use as a conduit for blood flow in the peripheral vasculature.

  • Long-term Patency*: Matracell® decellularization reduces vessel stenosis and improves long‑term patency by lowering risk of inflammation, thrombosis, and neointimal hyperplasia.1,2
  • Infection Resistance: A preferred choice for infected sites and patients at risk of infection as vascular allografts are reported to have low incidence of infection.3-7
  • Natural Healing and Integration*: A biohospitable matrix that supports cellular repopulation and proliferation with the appropriate native cells in the patient, fostering graft integration and long-term function.1,2,8,9
  • Early Access*: Graft can be accessed for hemodialysis as early as two weeks after implantation – at least 6X faster than an arteriovenous fistula.1,10
  • Proven Biomechanical Performance: Demonstrates strength and flexibility comparable to cryopreserved tissue, backed by rigorous ISO-standard testing.1,11
  • Unmatched Quality: Stringent graft selection and careful processing ensure that grafts have no sudden diameter changes or kinking, preserving hemodynamics which could help improve graft patency.2
  • Medical-Grade Safety: Maintains the highest level of sterility while preserving biomechanical strength and physiologic integrity.1,2,11,12
  • Optimized for Surgeons: Provides a familiar handling experience with compliance and suturability similar to native tissue. Available in a range of lengths and diameters to best match patient anatomy and meet surgical needs.1,11
  • Off-the-Shelf Convenience: Room temperature storage eliminates the need for liquid nitrogen (LN2) and ultra-cold freezers, streamlining OR logistics and improving efficiency.
     

*Based on a preclinical in vivo animal study.1 Results in animals may not be representative of results in humans.

Clinical Application
  • Arteriovenous Access for hemodialysis
  • Peripheral Vascular Disease (PVD) bypass
  • Peripheral Vascular Reconstruction
Room Temperature Description Sizing
DFA > 30 Decellularized Femoral Artery Length: > 30 cm / Outer Diameter Range: 4 mm - 10 mm
References
  1. Data on file LifeNet Health® ES-19-076.
  2. Data on file LifeNet Health® PQ-21-078.
  3. Bossi, M., Tozzi, M., Franchin, M., Ferraro, S., Rivolta, N., Ferrario, M., Guttadauro, C., Castelli, P., & Piffaretti, G. (2017). Cryopreserved human allografts for the reconstruction of aortic and peripheral prosthetic graft infection. Annals of Vascular Diseases, 10(4), 391-397. doi: 10.3400/avd.oa.17-00068
  4. Castier, Y., Francis, F., Cerceau, P., Besnard, M., Albertin, J., Fouilhe, L., Cerceau, O., Albaladejo, P. & Lesèche, G. (2005). Cryopreserved arterial allograft reconstruction for peripheral graft infection. Journalof vascular surgery, 41(1), 30-37. https://doi.org/10.1016/j.jvs.2004.09.025
  5. Harlander-Locke, M.P., Harmon, L.K., Lawrence, P.F., Oderich, G.S., McCready, R.A., Morasch, M.D., Feezor, R.J. & Vascular Low-Frequency Disease Consortium. (2014). The use of cryopreserved aortoiliac allograft for aortic reconstruction in the United States. Journal of vascular surgery, 59(3), 669-674. https://doi.org/10.1016/j.jvs.2013.09.009
  6. Madden, R. L., Lipkowitz, G. S., Browne, B. J., & Kurbanov, A. (2004). Experience with cryopreserved cadaveric femoral vein allografts used for hemodialysis access. Annals of vascular surgery, 18(4), 453-458. https://doi.org/10.1007/s10016-004-0055-0
  7. Mousavi, S. R., Moatamedi, M. R. K., & ME AKBARI, M. (2011). Comparing frozen saphenous vein with Gore-tex in vascular access for chronic hemodialysis. Hemodialysis International, 15(4), 559-562. https://doi.org/10.1111/j.1542-4758.2011.00578.
  8. Data on file LifeNet Health® PQ-11-005.
  9. Data on file LifeNet Health® ES-19-076Add1.
  10. Bylsma, L. C., Gage, S. M., Reichert, H., Dahl, S. L. M., & Lawson, J. H. (2017). Arteriovenous fistulae for haemodialysis: a systematic review and meta-analysis of efficacy and safety outcomes. European journal of vascular and endovascular surgery, 54(4), 513-522. https://doi.org/10.1016/j.ejvs.2017.06.024
  11. Data on file LifeNet Health® ES-19-064.
  12. Data on file LifeNet Health® PQ-10-008.