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Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery

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Abstract

Background

Laparoscopic staplers are integral to bariatric surgery. Their pricing significantly impacts the overall cost of procedures. An independent device company has designed a stapler handle and single-use reloads for cross-compatibility and equivalency with existing manufacturers, at a lower cost.

Objectives

We aim to demonstrate non-inferior function and cross-compatibility of a newly introduced stapler handle and reloads compared to our institution’s current stapling system in a large animal survival study.

Setting

University-affiliated animal research facility, USA.

Methods

Matched small bowel anastomoses were created in four pigs, one with each stapler (a total of two per animal). After 14 days, investigators blinded to stapler type evaluated the anastomoses grossly and microscopically. Each anastomosis was scored on multiple measures of healing. Individual parameters were added for a global “healing score.”

Results

Clinical stapler function and gross quality of anastomoses were similar between stapler groups. Individual scores for anastomotic ulceration, reepithelialization, granulation tissue, mural healing, eosinophilic infiltration, serosal inflammation, and microscopic adherences were also statistically similar. The mean “healing scores” were equal. While this study was underpowered for subtle differences, safe and reliable performance in large animals still supports the feasibility of introducing new devices into human use.

Conclusions

The new stapler system delivers a similar technical performance and is cross-compatible with currently marketed stapling devices. An equivalent quality device at a lower price point should enable case cost reduction, helping to maintain hospital case margin and procedure value in the face of potentially declining reimbursement. This device may provide a safe and functional alternative to currently used laparoscopic surgical staplers.

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Funding

Lexington Medical, Inc. (Billerica, MA, USA) however full editorial control for this paper remains with the authors as listed.

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Author notes

  1. Kurt E. Roberts and L. Renee Hilton contributed equally to this work.

Authors and Affiliations

  1. Department of Surgery, Gastrointestinal Section, Yale University, 40 Temple Street, Suite 7B, New Haven, CT, 06510, USA

    Kurt E. Roberts, L. Renee Hilton, Danielle T. Friedman & Andrew J. Duffy

  2. Department of Surgery, Minimally Invasive and Digestive Diseases, Augusta University, Augusta, GA, USA

    L. Renee Hilton

  3. Universidad Central de Venezuela, Caracas, Venezuela

    Joel S. Frieder

  4. Department of Surgical Pathology, Yale University, New Haven, CT, 06520, USA

    Xuchen Zhang

Authors
  1. Kurt E. Roberts
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  2. L. Renee Hilton
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  4. Joel S. Frieder
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Corresponding author

Correspondence to Danielle T. Friedman.

Ethics declarations

All applicable institutional and national guidelines for the care and use of animals were followed.

Conflict of Interest

Kurt E. Roberts M.D. is a consultant for Lexington Medical, Inc. receiving consultation fee and stock options for services, and was paid only for the time of the trial. L. Renee Hilton M.D. was paid by Lexington Medical, Inc. for the time of the trial.

Danielle T. Friedman M.D. has nothing to disclose. Joel S. Frieder M.D. is a research intern for Lexington Medical, Inc. and has no financial compensation. Xuchen Zhang M.D., Ph.D. has nothing to disclose. Andrew J. Duffy M.D. is a consultant for Lexington Medical, Inc. receiving consultation fee and stock options for services and was paid only for the time of the trial.

Additional information

Kurt E. Roberts and L. Renee Hilton are co-first authors.

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Roberts, K.E., Renee Hilton, L., Friedman, D.T. et al. Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery. OBES SURG 29, 401–405 (2019). https://doi.org/10.1007/s11695-018-3580-6

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  • DOI: https://doi.org/10.1007/s11695-018-3580-6

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