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Objective <p>To evaluate the safety and effectiveness of using self-forming magnets (SFM) with an immediately functional lumen for the creation of small bowel anastomoses.</p> Background <p>Prevention of short-, medium-, and long-term gastrointestinal anastomotic complications remains a clinical challenge. Magnetic compression techniques with the ability to provide an immediately functional lumen may provide safer and more consistent anastomoses with reduced risk of leak, bleed, and/or stricture.</p> Methods <p>This multicenter, prospective, single-arm pivotal clinical study evaluated the Flexagon 25&#xa0;mm SFM system plus OTOLoc in adult patients undergoing laparoscopic surgery requiring the creation of a small bowel anastomosis<b>.</b> The primary endpoint was defined as successful anastomosis created with the SFM with immediate functional lumen technique without placement procedure, device, or target anastomosis-related reoperation through 30&#xa0;days. Adverse events were monitored and classified per Clavien–Dindo criteria.</p> Results <p>Across six centers, 79 patients underwent laparoscopic small bowel anastomosis creation with an SFM that provided an immediately functional lumen. All patients achieved the primary study endpoint. There were no reported cases of small or large bowel obstruction, anastomotic bleed, leak, re-intervention, or death. The most common adverse events included abdominal pain (35 cases), nausea (21), and incision site pain (21), with only four serious adverse events. There were no serious device-related adverse events. Median (interquartile range) procedure and anastomosis creation times were 92 (76, 116) and 13 (9, 17) minutes, respectively.</p> Conclusion <p>This clinical trial highlights the technical and clinical success and the short-term safety profile of an SFM system that provides an immediately functional lumen for the creation of a small bowel anastomosis. The results provide a robust platform for future controlled and comparative studies to more comprehensively define the role of magnetic compression anastomosis in gastrointestinal surgery.</p> Graphical abstract <p></p>

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The functional lumen opening with self-forming magnetic anastomosis (FLOWS) study: results from the North American pivotal trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月31日

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  • Andre Teixeira,
  • Michael Seger,
  • Nestor De la Cruz Munoz Jr,
  • Dana Portenier,
  • Pearl Ma,
  • Muhammad Ghanem,
  • Richard Englehardt,
  • Melissa Felinski,
  • Kelvin Higa,
  • Manoel Galvao Neto,
  • Shinil K. Shah

摘要

Objective

To evaluate the safety and effectiveness of using self-forming magnets (SFM) with an immediately functional lumen for the creation of small bowel anastomoses.

Background

Prevention of short-, medium-, and long-term gastrointestinal anastomotic complications remains a clinical challenge. Magnetic compression techniques with the ability to provide an immediately functional lumen may provide safer and more consistent anastomoses with reduced risk of leak, bleed, and/or stricture.

Methods

This multicenter, prospective, single-arm pivotal clinical study evaluated the Flexagon 25 mm SFM system plus OTOLoc in adult patients undergoing laparoscopic surgery requiring the creation of a small bowel anastomosis. The primary endpoint was defined as successful anastomosis created with the SFM with immediate functional lumen technique without placement procedure, device, or target anastomosis-related reoperation through 30 days. Adverse events were monitored and classified per Clavien–Dindo criteria.

Results

Across six centers, 79 patients underwent laparoscopic small bowel anastomosis creation with an SFM that provided an immediately functional lumen. All patients achieved the primary study endpoint. There were no reported cases of small or large bowel obstruction, anastomotic bleed, leak, re-intervention, or death. The most common adverse events included abdominal pain (35 cases), nausea (21), and incision site pain (21), with only four serious adverse events. There were no serious device-related adverse events. Median (interquartile range) procedure and anastomosis creation times were 92 (76, 116) and 13 (9, 17) minutes, respectively.

Conclusion

This clinical trial highlights the technical and clinical success and the short-term safety profile of an SFM system that provides an immediately functional lumen for the creation of a small bowel anastomosis. The results provide a robust platform for future controlled and comparative studies to more comprehensively define the role of magnetic compression anastomosis in gastrointestinal surgery.

Graphical abstract