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Conservative Safety Assessment of a Nitinol Microhook Coaptation Device on Intact Nerve
Jonathan Isaacs1, Geetanjali S Bendale1, Ananya Gomatam2
1Division of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.
Muscle & Nerve
|July 14, 2026
Summary
Nerve Tape, a novel nerve coaptation device, showed no adverse effects on intact nerves compared to sutures or SIS alone. Its components, Nitinol microhooks and SIS, were well-tolerated in a preclinical study.
Area of Science:
- Biomaterials Science
- Regenerative Medicine
- Neurosurgery
Background:
- Microsuturing for nerve coaptation presents technical challenges.
- Nerve Tape is a novel device using Nitinol microhooks and small intestine submucosa (SIS) for nerve repair.
- Previous studies demonstrated its safety and efficacy in nerve injury models.
Purpose of the Study:
- To evaluate the impact of Nerve Tape components on intact nerve tissue and function.
- To compare Nerve Tape to traditional sutures and SIS alone in a conservative preclinical model.
Main Methods:
- Nerve Tape, sutures, or SIS were applied to intact rabbit tibial nerves.
- After three months, nerves and muscles were assessed for scarring, inflammation, and function.
- Evaluations included gross inspection, morphology, electrophysiology, and histology.
Main Results:
- No significant differences in nerve function (NCAP, conduction velocity) or axon counts were observed between groups.
- Sutures showed increased adhesion thickness, granulomas, and neovascularization compared to Nerve Tape.
- SIS material was associated with inflammatory cell presence, while Nitinol components showed no adverse tissue response.
Conclusions:
- Nerve Tape, with its SIS and Nitinol microhook design, maintained intact nerve health.
- The device demonstrated comparable or superior tissue response to sutures and SIS alone.
- Nerve Tape offers a safe and effective alternative for nerve coaptation.
