Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

Exclusion Criteria

• •1. Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions;
• •2. Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc);
• •3. Have a life expectancy of less than 12 months;
• •4. Have a history of or planned radiotherapy in the area of the end-neuroma;
• •5. be contraindicated for soft tissue implants.; this includes but is not limited to any pathology that would limit the blood supply; compromise healing or indicate the presence of a local infection;
• •6. Have a history of chronic ischemic conditions of the extremity;
• •7. Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator);
• •8. Have a history of diabetic neuropathy;
• •9. Be undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system;
• •10. Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy within 12 months following the study procedure;
• •11. Have a History of congenital neuropathy or compressive neuropathy affecting the target limb;
• •12. Have a history of prior surgical management of more proximal compressive neuropathies or spinal conditions (e.g. spinal stenosis) not related to the symptomatic neuroma that affect the target limb;
• •13. Currently use or likely need to use medication during the study known to impact nerve regeneration or to cause peripheral neuropathy;
• •14. Be pregnant or plan to become pregnant during the duration of the study;
• •15. Be or have been enrolled in another interventional study within 30 days prior to consenting;
• •16. Have a known allergy to anesthetic agents;
• •17. Have a known sensitivity to porcine derived materials; or
• •18. Be, in the opinion of the Investigator, unsuitable for inclusion in the study.