The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned.
For this expanded access program, there is a case-by-case internal review process conducted by Neuraptive after the respective investigator provides a prospective case narrative for enrollment consideration. Allowed Sunderland Classifications are IV degree (Seddon's Class II) and V degree (Seddon's Class III). If the case is approved, the investigator can move forward. Patients who are between twelve (12) and eighty (80) years of age and has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and require surgical treatment. All peripheral nerve repairs including gap repairs (autografts) will be considered for enrollment.
Study Type
EXPANDED_ACCESS
One-time use surgical product of three solutions and a device
Orlando Health Orthopedic Institute
Orlando, Florida, United States
AVAILABLEHarborview Medical Center
Seattle, Washington, United States
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