Evaluation of the AEON Powered Stapler System in Primary Sleeve Gastrectomy: Results of a Prospective Clinical Trial

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Evaluation of the AEON Powered Stapler System in Primary Sleeve Gastrectomy: Results of a Prospective Clinical Trial

Antanas Mickevicius, Agne Sikarske, and Mindaugas Kiudelis

Journal of Metabolic and Bariatric Surgery (JMBS), August 2026

1.04 / 5.0
Mean intraoperative staple-line bleeding score: near-perfect hemostasis
(1 = no bleeding · 5 = profuse bleeding)
0
Staple-line bleeds, leaks, or reoperations
n = 50
Prospective single-arm trial
Key finding: Prospective single-arm trial of 50 consecutive patients undergoing primary laparoscopic sleeve gastrectomy with the AEON™ Powered Stapling System. Mean intraoperative staple-line bleeding score was 1.04 on a validated 1 to 5 visual analogue scale, assessed by a blinded independent evaluator. No patient experienced clinically significant staple-line bleeding, and there were no postoperative staple-line bleeds, leaks, reoperations, or device-related adverse events. No staple-line reinforcement was used in any case.
Bleeding Severity Scale showing five surgical staple line images ranging from no bleeding to profuse bleeding

Bleeding Severity Scale, showing five intraoperative images of a staple line at increasing bleeding severity: (1) no bleeding, (2) minimal bleeding, (3) moderate bleeding, (4) excessive bleeding, (5) profuse bleeding.

Source: Figure 1. Bleeding Severity Scale, from Antanas Mickevicius, Agne Sikarske, and Mindaugas Kiudelis, published in J Metab Bariatr Surg. 2026;15(2):103–112. https://doi.org/10.17476/jmbs.2026.15.2.103. © 2026 The Korean Society for Metabolic and Bariatric Surgery, August 2026. Licensed under CC BY-NC 4.0 (https://creativecommons.org/licenses/by-nc/4.0/).

Abstract

Materials and Methods
This was a prospective, single-center, single-arm study including 50 consecutive patients undergoing primary sleeve gastrectomy using the AEON Powered Stapling System. The primary endpoint was postoperative staple-line complications requiring intervention (bleeding or leak). Intraoperative hemostasis was assessed using a visual analogue scale (VAS). Postoperative outcomes and early quality-of-life (QOL) changes were evaluated.

Results
Fifty patients (49 female; mean age 38.5±7.4 years; mean body mass index 35.8±3.7 kg/m2) underwent sleeve gastrectomy. Mean intraoperative VAS bleeding score was 1.04±0.19. No intraoperative bleeding requiring intervention occurred. There were no postoperative staple-line bleeds, leaks, reoperations, or device-related adverse events. Mean hemoglobin decrease was clinically insignificant, and no blood transfusions were required. Early postoperative pain scores were low and decreased progressively until discharge. In an exploratory analysis, improvement in five 36-Item Short Form Health Survey QOL domains was observed at 3 weeks.

Conclusion
The AEON Powered Stapling System was safe and effective and demonstrated low intraoperative staple-line bleeding scores and a favorable short-term safety profile in primary sleeve gastrectomy. Because this was a single-arm study without a comparator group, larger comparative studies with longer follow-up are warranted.

Trial Registration
ClinicalTrials.gov Identifier: NCT06474637

Keywords
Sleeve gastrectomy; Powered stapler; Staple-line bleeding; Bariatric surgery

Clinical Relevance: Stapler-related complications, including staple-line bleeding, leak, and stenosis, occur in approximately 5% of bariatric cases and remain a persistent source of morbidity despite standardized technique. Staple-line reinforcement can reduce these risks but adds cost and operative time to every procedure. This trial is the first prospective clinical evaluation of the AEON Powered Stapling System in sleeve gastrectomy, and reports low intraoperative bleeding scores and no staple-line complications across 50 consecutive cases performed without any buttressing material. For bariatric surgeons weighing whether reinforcement is a necessary default, the finding is directly relevant, though it should be interpreted as a safety and feasibility signal rather than a comparative result. As the authors note, this was a single-center, single-arm study without a control group and cannot support conclusions of superiority over other devices. Comparative studies with longer follow-up are warranted.
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