Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery
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.
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.
University-affiliated animal research facility, USA.
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.”
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.
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.
KeywordsBariatric surgery Surgical devices Value New technology
Lexington Medical, Inc. (Billerica, MA, USA) however full editorial control for this paper remains with the authors as listed.
Compliance with Ethical Standards
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.
- 3.Soper NJ, Brunt M, Fleshman Jr J, et al. Laparoscopic small bowel resection and anastomosis. Surg Laparosc Endosc. 1993;3(1):6–12.Google Scholar
- 7.U.S. Food and Drug Administration Medical Device Database. 510(k) Premarket Notification. Via website: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171589.pdf Accessed 16 February 2018.
- 8.Covidien. Endo GIA™ Reloads with Tri-Staple™: Technical Brochure 2011.Google Scholar
- 9.Steichen FM. The use of staplers in anatomical side-to-side and functional end-to-end enteroanastomoses. Surgery. 1968;64:948–53.Google Scholar
- 13.Stahl R. Laparoscopic anastomotic techniques. SAGES (Society of American Gastrointestinal and Endoscopic Surgeons). 2012. Website: sages.org /wiki/laparoscopic-anastomotic-techniques. Accessed 19 June 2017.
- 15.Steichen FM. Problems and complications associated with the use of stapling. Probl Gen Surg. 1985;2:18–30.Google Scholar
- 19.Steichen FM, Ravitch MM. Stapling in surgery. Chicago: Year Book Medical Publishers Inc; 1984. p. 270–311.Google Scholar
- 20.Soper NJ, Barteau JA, Clayman RV, et al. Comparison of early postoperative results for laparoscopic vs. standard open cholecystectomy. Surg Gynecol Obstet. 1992;174:114–8.Google Scholar