This multicenter, prospective, single-arm FDA IDE pivotal trial evaluated the Flexagon 25 mm self-forming magnet (SFM) system plus OTOLoc for laparoscopic small bowel anastomosis creation with an immediately functional lumen in 79 adult patients across 6 U.S. centers (September 2024–March 2025), with 30-day primary endpoint follow-up and 60-day safety monitoring.
100% of patients (79/79, including 71 in the primary mITT cohort and 8 roll-in) met the primary endpoint of successful anastomosis without reoperation through 30 days. There were zero anastomotic leaks, bleeds, obstructions, re-interventions, or deaths. Only 4 serious adverse events occurred (2 intraoperative small bowel perforations repaired at index operation, 1 pneumonia, 1 C. difficile colitis). Median anastomosis creation time was 13 minutes (IQR 9–17).
- Single-arm design with no comparator group limits conclusions about superiority over stapled/sutured techniques. - Short follow-up (30–60 days) cannot capture medium- or long-term complications such as stricture, marginal ulcer, or intussusception. - Study was industry-funded and primarily performed in low-risk elective bariatric/metabolic cases, limiting generalizability to higher-risk or acute-care settings.
The Flexagon SFM system created laparoscopic small bowel anastomoses with no leaks, bleeds, or obstructions in this pivotal cohort, and median anastomosis time was just 13 minutes. Clinicians should note that MRI is contraindicated until magnets pass (~8–14 days), and long-term data are still needed before broader adoption beyond elective small bowel cases.
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