Evidence map›Paper›PMID 42446250›Full record

ArticleMuscle & nerve2026

Conservative Safety Assessment of a Nitinol Microhook Coaptation Device on Intact Nerve.

Jonathan Isaacs, Geetanjali S Bendale, Ananya Gomatam, Hope T Richard, Charles Reiter, Kush Savsani, Marc Mazur, Taylor Allen, Noah Clough

Abstract read
In one paragraph

Article in Muscle & nerve, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jonathan IsaacsDivision of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.
Geetanjali S BendaleDivision of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.
Ananya GomatamWilliam & Mary, Williamsburg, Virginia, USA.
Hope T RichardDepartment of Pathology, Virginia Commonwealth University Health System, Richmond, Virginia, USA.ORCID https://orcid.org/0000-0002-5956-0585
Charles ReiterDivision of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.
Kush SavsaniDivision of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.
Marc MazurDivision of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.
Taylor AllenDivision of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.
Noah CloughDivision of Hand Surgery, Department of Orthopaedic Surgery, Virginia Commonwealth University Health System, Richmond, Virginia, USA.

Funding

BCT FP00022120
6 · The paper itself

Abstract

INTRODUCTION/

aimsNerve Tape is a novel nerve coaptation device that eliminates the technical challenges of microsuturing. The device incorporates tissue-engaging Nitinol microhooks within a flexible backing of decellularized porcine small intestine submucosa (SIS). Preclinical nerve injury models have demonstrated device safety and effective promotion of regeneration and recovery. Here, we further assess the impact of the device's components on nerve tissue and function, using a highly conservative model in which the device is applied to intact nerves.

methodsNerve Tape, sutures, or SIS were applied to rabbit tibial nerves in a manner simulating transection repairs but leaving the nerves intact. After three months, "repaired" nerves and target gastrocnemius muscles along with contralateral control nerves and muscles were evaluated for perineural scarring, inflammation, and function utilizing gross inspection, morphology measurements, electrophysiology, and histology.

resultsAnalysis of endpoint data, including muscle mass/girth, nerve compound action potential (NCAP) amplitude, conduction velocity, axon counts, and g-ratio revealed no significant differences between experimental or control groups (distal axon count/g-ratio: Nerve Tape 6546 ± 2300, 0.647 ± 0.04; Suture 7979 ± 666, 0.664 ± 0.033; SIS 7537 ± 2117, 0.689 ± 0.02; control 6158 ± 1958, 0.631 ± 0.02). Gross adhesion thickness at the treatment site was higher in the Suture group versus the Nerve Tape group. Granulomas and neovascularization were most pronounced in the Suture group. Macrophage/lymphocyte/plasma cell presence was associated with SIS material. No additional tissue response was observed in response to Nitinol components. DISCUSSION: Nerve Tape's SIS and Nitinol microhook design maintained the health of an intact nerve with sequelae comparable to sutures or SIS without microhooks.

Indexed as

AlloysTibial NerveAction PotentialsAnimalsFemaleMuscle, SkeletalNerve Conduction StudiesNerve RegenerationNeural ConductionRabbitsSwineAlloysnitinolmicrosuturesnerve coaptationNerve TapeSIS

Identifiers

PMID42446250
PMCPMC13471752

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.