This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.
Nerve diameter at injury site ≤3mm.
Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.
For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
Previous history of nerve repair attempt at the treated nerve.
Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
Pregnancy or planning to become pregnant
Auxilium Biotechnologies
Lead sponsor
MCRA
Collaborator