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Dual Tack Mesh Fixation System on a Cadaveric Porcine Model—Creation of a Mesh Fixation System for Hernia Treatment and Prevention

  • Omar Elfanagely
  • , Sammy Othman
  • , Jonathan A. Sanchez
  • , Arturo Rios-Diaz
  • , Joseph A. Mellia
  • , John P. Fischer
  • University of Pennsylvania
  • Paradigm Surgical LLC

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Onlay mesh repair (OMR) has proven to be a widely used, simple, and effective technique for treatment and prevention of hernia occurrence. Despite established benefits, there is still a lack of widespread adoption. In this study, we present the Dual Tacker Device (DTD), an enabling technology that directly addresses the limitations to the adoption of OMR, saving surgical time and effort and making OMR more reproducible across a wide range of patients. Methods: The DTD mesh fixation system is a semiautomated, hand-held, disposable, multipoint onlay mechanical mesh fixation system that is able to rapidly and uniformly tension and fixate mesh for both hernia treatment and prevention. A cadaveric porcine model was used as a pilot test conducted during a 2 day session to assess the usability of the device and to show that the DTD provided equivalent or superior biomechanical support compared with the standard of care (hand-sewn, OptiFix). Results: Our study included 37 cadaveric porcine incisional closure abdominal wall models. These were divided into four groups: DTD-mediated OMR (n = 14), hand-sewn OMR (n = 7), OptiFix OMR (n = 9), and suture-only repair (no mesh) (n = 7). Eight surgical residents performed device-mediated and hand-sewn OMR. Average time to completion was fastest in the DTD cohort (45.6s) with a statistically significant difference compared with the hand-sewn cohort (343.1s, P < 0.01). No difference in tensile strength was noted between DTD (195.32N), hand-sewn (200.48N), and OptiFix (163.23N). Discreet hand movements were smallest in the DTD (29N) and significant (P < 0.01) when compared with hand-sewn (202N) and OptiFix (35N). Conclusions: The use of the DTD is not only feasible, but demonstrated improvement in time to completion and economy of movement over current standard of care. While more testing is needed and planned, compared with conventional approaches, the DTD represents a robust proof of principle with promising implications for clinical feasibility and adoptability.

Original languageEnglish
Pages (from-to)317-325
Number of pages9
JournalJournal of Surgical Research
Volume257
DOIs
StatePublished - Jan 2021
Externally publishedYes

Keywords

  • Hernia device
  • Mesh fixation
  • Onlay mesh repair
  • Ventral hernia

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