Magnetic bipartition feasible, safe and effective in achieving incisionless, suture/staple-free duodeno-ileostomy

An innovative technique using a biofragmentable magnetic anastomosis system (BMAS) to effect magnetic duodeno-ileostomy (MagDI) bipartition, could be a promising minimally invasive option for patients with mild obesity and T2DM, according to the outcomes for a first-in-human investigation, led by Professor Michel Gagner, an innovator in the development of laparoscopic sleeve gastrectomy and magnetic anastomosis from Westmount Square Surgical Center, Westmount, QC, Canada.

Intraoperative view of distal BMAS magnet placed in the ileum paired with the proximal BMAS magnet (located approximately 2 cm distal to the pylorus).

The researchers hypothesised that an anastomosis creation using a novel magnetic compression technique may provide an alternative minimally invasive approach to gastrointestinal surgery. The BMAS is endo-laparoscopically placed to effect MagDI, which avoids major risks associated with enterotomy, stapling/suturing and retained foreign materials.

Endoscopic views of patent magnetically created duodeno-ileal anastomosis.

This first-in-human prospective investigation assessed the feasibility, safety and efficacy in adults with body mass index (BMI) ≥30.0 to ≤35.0 kg/m2. An initial BMAS magnet, swallowed by the patient or delivered under anaesthesia by endoscopy, was guided laparoscopically to the distal ileum; a second magnet was endoscopically positioned in the post-pyloric duodenum; magnets were aligned to fuse over 7-21 days forming the duodeno-ileostomy. Primary endpoints were the feasibility and severe adverse event (SAEs) incidence by Clavien-Dindo (CD) grade. Secondary endpoints looked at weight and T2DM reduction.

From December 2022 and May 2024, 15 patients (mean BMI 33.0±0.4 kg/m2), all with T2DM (HbA1C 8.2±0.4%, glucose 187.9±15.5 mg/dL, on T2DM medications) underwent MagDI. After the sub-1-hour operation (mean operative time, 51.3±5.3 minutes), feasibility at 90 days was confirmed at 100% and no leakage, bleeding, infection, stricture, or mortality, and at 1-year follow up, all anastomoses were patent. In addition, eight patients who continued to follow up for weight and T2DM showed excess weight loss of 38.8% and HbA1C reduction of approximately 1.5 percentage points (8.2 to 6.6±0.1%). In addition, 89.4% of AEs were mild; 3 CD-III SAEs were resolved.

“The novel swallowable, biofragmentable magnetic anastomosis system was feasible, safe, and effective in achieving incisionless, suture/staple-free magnetic duodeno-ileostomy,” the authors concluded. “The device and procedure provide a promising minimally invasive option for moderate, clinically meaningful weight loss and T2D mitigation.”

The outcomes were featured in the paper, ‘First-in-Human Side-to-Side Duodeno-Ileal Bipartition for Weight Loss and Type 2 Diabetes with the Swallowable Biofragmentable Magnetic Anastomosis System’, published in Journal of the American College of Surgeons. To access this paper, please click here (log-in maybe required).