Nexeon ® Advanced Vascular Allograft Landing Page

Nexeon®

ADVANCED VASCULAR ALLOGRAFT

Give your procedure—and your
patient’s future—every advantage.

The world’s first decellularized,
sterile, room temperature vascular allograft.

Support your patients’ goals by giving healing every advantage. Intended for use as a conduit for blood flow in the peripheral vasculature, Nexeon revolutionizes care for patients with peripheral vascular disease (PVD), kidney failure requiring hemodialysis, vascular trauma reconstruction, and beyond.

Addressing Unmet Needs in Vascular Surgery

Long-Term Patency*

Processed with Matracell® decellularization technology, Nexeon reduces vessel stenosis and improves long-term patency by lowering risk of inflammation, thrombosis, and neointimal hyperplasia.1,2*

Resistance to Infection

Nexeon is 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

Off-the-Shelf
Convenience

Nexeon is the first and only vascular allograft to be stored at room temperature, which streamlines OR logistics by eliminating the need for liquid nitrogen, ultracold freezers, and refrigerators.

*Based on a preclinical in vivo animal study.2 Results in animals may not be representative of results in humans.

Made Possible by Matracell®
Decellularization Technology

Matracell removes >99% of donor cells and DNA while preserving biomechanical strength and tissue integrity.1,8-13

Nexeon is processed using LifeNet Health’s validated and patented Matracell decellularization technology, which yields a strong, acellular scaffold that supports cell migration and constructive remodeling.9,10,14-17

Only tissue processed with Matracell meets the threshold of being truly decellularized, evidenced by the absence of nuclear material (i.e., DNA), assessed both quantitatively and by histology, as well as an absence of intact cells on immunohistochemistry.18

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More Reasons to Choose Nexeon

Optimized for Surgeons

Handling, compliance, and suturability similar to native tissue2,8

Early Access*

Graft can be accessed for hemodialysis as early as two weeks after implantation – at least 6X faster than an arteriovenous fistula2,22*

Unmatched Quality

Stringent graft selection and careful processing ensure that grafts have no sudden diameter changes or kinking1

Natural Healing and Integration*

A biohospitable matrix that supports cellular repopulation and proliferation with the appropriate native cells in the patient1,2,20,21*

Proven Biomechanical Performance

ISO-standard testing demonstrates strength and flexibility comparable to cryopreserved tissue2,8

Medical-Grade Safety

Maintains the highest level of sterility while preserving biomechanical strength and physiologic integrity1,2,8,23

*Based on a preclinical in vivo animal study.2 Results in animals may not be representative of results in humans.

Clinical Applications

  • Arteriovenous access for hemodialysis
  • Peripheral Vascular Disease (PVD) bypass
  • Peripheral Vascular Reconstruction

Resources

Instructions for Use
Product Specifications

References

  1. Data on file LifeNet Health® PQ-21-078.
  2. Data on file LifeNet Health® ES-19-076.
  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. Journal of 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® ES-19-064.
  9. Data on file LifeNet Health® TR-0056.
  10. Data on file LifeNet Health® TR-0082. 
  11. Data on file LifeNet Health® TR-0035. 
  12. Data on file LifeNet Health® TR-0030.
  13. Wolfinbarger, Jr.; Lloyd; Lange; Perry; Linthurst; Alyce; Moore; Eric; Nolf; Barry.  2004.   
Process for devitalizing soft-tissue engineered medical implants, and devitalized soft tissue medical implants produced U.S. Patent Number 6,743,574.
  14. Data on file LifeNet Health® PQ-07-078. 
  15. Lofland, G. K., O'Brien Jr, J. E., Gandy, K. L., Dennis, P. A., Marshall, J. A., Mastbergen, R. K., & Hopkins, R. A. (2012). Initial pediatric cardiac experience with decellularized allograft patches. The Annals of thoracic surgery, 93(3), 968-971.
  16. Hopkins RA, Lofland GK, Marshall J, Connelly D, Acharya G, Dennis P, Stroup R, McFall C, O'Brien JE Jr. Pulmonary arterioplastywith decellularized allogeneic patches. Ann ThoracSurg. 2014 Apr;97(4):1407-12. doi: 10.1016/j.athoracsur.2013.12.005
  17. Bonilla-Ramirez C, Aggarwal V, Atyam M, Qureshi AM, Heinle JS, McKenzie ED. Decellularized Vs Non-decellularized Allogeneic Pulmonary Artery Patches for Pulmonary Arterioplasty. Seminars in Thoracic and Cardiovascular Surgery. 2022. https://doi.org/10.1053/j.semtcvs.2022.07.005.
  18. Crapo PM, Gilbert TW, Badylak SF. An overview of tissue and whole organ  
decellularization process. Biomaterials. 2011;32(12):3233-3243. doi: 10.1016/j.biomaterials.2011.01.057.
  19. Data on file LifeNet Health® ES-20-001.
  20. Data on file LifeNet Health® PQ-11-005.
  21. Data on file LifeNet Health® ES-19-076Add1.
  22. 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
  23. Data on file LifeNet Health® PQ-10-008. 

EX 3486.00