In vivo safety of a novel nerve coaptation device on an intact nerve in a rabbit model
Geetanjali S Bendale, PhD1, Charles Reiter, BS1, Noah Clough, BS1, Kush Savsani, BS1, Ryan Clement, PhD2, Jules McNeice, MS2, Isaac Clements, PhD2 and Jonathan Isaacs, MD3, 1Virginia Commonwealth University, Richmond, VA, 2BioCircuit Technologies, Atlanta, GA, 3Department of Orthopaedics, Virginia Commonwealth University, Richmond, VA
Introduction: Microsuture neurorrhaphy is resource expensive, requires microsurgical proficiency, and often fails to achieve acceptable nerve end alignment. Repair site entubulation may enhance nerve alignment but still requires microsuture placement. Nerve Tape is a novel, sutureless coaptation device offering the potential advantages of entubulation without the technical challenges of microsuturing. The device incorporates opposing tissue grabbing Nitinol microhooks within a flexible decellularized porcine small intestine submucosa (SIS) extracellular matrix backing. Preclinical efficacy has been well established in small animal nerve repair models though concerns regarding iatrogenic morbidity remain.
Materials and Methods: The present study was conducted to further investigate the safety of Nerve Tape utilizing an intact nerve model, in which the device is wrapped around a healthy nerve as a conservative test case. Rabbit sciatic nerves were implanted with either 1) suture, 2) SIS wrap plus suture, or 3) Nerve Tape, and assessed after one month of implantation. An additional group of animals was implanted with the Nerve Tape device for 3months and compared with a healthy, naïve nerve.
Results: Analysis of 1 month endpoint data, including muscle mass/girth, nerve compound action potential (NCAP) amplitude, conduction velocity, axon counts, or g-ratio revealed no significant differences among groups. in the SIS wrap group (5.4 ± 0.7 mm) as compared to either the Suture group (3.5 ± 0.5 mm, p < 0.0001 Wilcox) or Nerve Tape group (4.0 ± 0.7 p < 0.005 Wilcox). At 3 months, there was no significant difference in muscle mass and girth, axon counts, g-ratios, and nerve conduction of the Nerve Tape group as compared to healthy control nerves. Histopathology showed minimal signs of inflammation.
Conclusion: This study suggests that the Nitinol microhooks present in Nerve Tape do not negatively impact the health of an intact nerve, as compared to either sutures, or SIS wrap without microhooks and has no long-term negative effects on intact axons.
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