NeuroSpan Bridge

The NeuroSpan Bridge is a biodegradable implant made from polycaprolactone with internal microchannels, designed to repair peripheral nerve injuries by bridging gaps between transected nerve ends and providing a protective environment for axonal growth. It is flexible, suturable, sterile, single-use, and available in multiple diameter and length variations. It is indicated for repair of peripheral nerve discontinuities where tensionless repair can be achieved through extremity flexion.

The subject device features a tubular structure with multiple internal microchannels (200-300 µm diameter), made from polycaprolactone, with suturing overhangs marked for depth guidance. The predicate NeuroGen Nerve Guide is a hollow tubular collagen device. Both are biodegradable, suturable, resorbable, supplied sterile for single use in multiple sizes, sterilized by ethylene oxide, and designed to support nerve regeneration using the same implantation techniques.

ISO 10993-1 (biological evaluation), ISO 10993-3 (genotoxicity), ISO 10993-4 (hemocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (pyrogenicity and acute toxicity), ISO 10993-23 (irritation), ISO 11135:2014 (sterilization), ASTM D4169-22 (transportation), and ASTM F756 (hemolysis testing).

Comparative bench testing and two GLP animal studies (rat and rabbit sciatic nerve transection models) demonstrated that the NeuroSpan Bridge performs similarly to the predicate device in mechanical properties, biocompatibility, safety, and nerve regeneration outcomes. Both devices showed equivalent inflammatory responses, biodegradation profiles, functional assessments, and histological responses, establishing substantial equivalence despite the difference in internal structure (microchannels vs. open lumen) and material (polycaprolactone vs. collagen).