Biomechanical Testing of a Novel Device for Sutureless Nerve Repair.

Suboptimal nerve end alignment achieved with conventional nerve repair techniques may contribute to poor clinical outcomes. In this study, we introduce Nerve Tape®, a novel nerve repair device that integrates flexible columns of Nitinol microhooks within a biologic backing to entubulate, align, and secure approximated nerve ends. This study compares the repair strength of Nerve Tape with that of conventional microsuture repairs. Thirty small (2 mm) and 30 large (7 mm) diameter human cadaveric nerves were transected and repaired utilizing Nerve Tape or appropriate microsuture technique. Biomechanical testing was performed using a horizontal tensile tester. The repaired nerves were loaded until failure at a distraction rate of 40 mm/min, and the maximum failure load was determined. In the small nerve groups, the load-to-failure for Nerve Tape repairs (2.33 ± 0.66 N) was significantly higher than for suture repairs (1.22 ± 0.52 N; p < 0.05). In the large nerve groups, no significant difference in load-to-failure was found between Nerve Tape (7.45 ± 2.66 N) and suture repairs (5.82 ± 1.59 N: p = 0.12). Suture repairs tended to fail by rupture, whereas Nerve Tape failures resulted from microhook pullout. Nerve Tape is a novel nerve coaptation device that provides mechanical repair strength equal or greater to clinically relevant microsuture repairs.