Biofragmentable magnetic anastomosis system is feasible, safe and effective in achieving incisionless, suture- or staple-free MagDI bipartition

Researchers from Canada and the Republic of Georgia have found the swallowable, biofragmentable magnetic anastomosis system (BMAS) was feasible, safe and effective in achieving incisionless, suture- or staple-free magnetic duodenoileostomy (MagDI) bipartition, at one year follow-up. They reported the device and procedure provide a promising minimally invasive option for moderate, clinically meaningful weight loss and T2DM mitigation.

The MagDI System is a self-aligning, incisionless, sutureless, and staple-free technology designed to facilitate anastomosis while leaving behind no foreign material

The study authors stated that anastomosis creation using a novel magnetic compression technique may provide an alternative minimally invasive approach to gastrointestinal surgery. The biofragmentable magnetic anastomosis system (BMAS) is endolaparoscopically placed to effect magnetic duodenoileostomy (MagDI) bipartition for reduction of weight and type 2 diabetes (T2D). MagDI obviates major risks associated with enterotomy, stapling or suturing, and retained foreign materials.

This study evaluated the first-in-human (FIH) solo MagDI with a biofragmentable magnetic anastomosis system (BMAS), a second-generation linear MAS to treat patients with mild obesity (BMI ≥ 30.0 to 40.0 kg/m2) and T2DM. The device flange gradually dissolves at seven to 21 days after placement to optimise anastomotic healing before release of the magnets from the surrounding tissue and device expulsion. The feature also enables the magnet to be swallowed by the patient, eliminating one of two endoscopic procedures, further minimising invasiveness.

The study design was a prospective, open-label, FIH, single-centre observation of the feasibility and proof of concept of the investigational biofragmentable magnetic anastomosis system in the MagDI procedure for up to 20 enrolled patients with mild obesity and T2DM.

The primary study endpoint was feasibility at 90 days based on (1) correct placement and alignment of the BMAS magnets, (2) expulsion of magnets without surgical reintervention for device-related AEs, and (3) radiologically confirmed patent MagDI anastomoses. The primary endpoint was considered achieved if BMAS performed as designed in ≥80% of treated patients.

The safety endpoint was an incidence of device- and procedure-related AEs and SAEs (ie SAEs requiring intervention comparable or better than benchmarks reported in the scientific literature for MBS procedures using conventional anastomosis stapling or suturing (as gauged by the Clavien-Dindo (CD) classification of surgical complications [grades 1 to 5]). Secondary endpoints were weight and T2DM reduction.

The MagDI System (GT Metabolic Solutions) consists of 2 BMAS magnets with a metabolic delivery system and a metabolic laparoscopic positioning device. The magnets are composed of a neodymium-iron-boron magnetic core enclosed in a biocompatible Parylene C coating, which in turn is encased in a titanium alloy housing. The delivery system is a flexible orogastric catheter used to engage the duodenoileal magnet and advance it intraluminally through the duodenum. Laparoscopic positioning devices of various magnetic strengths are provided to facilitate repositioning of the distal magnet during the MagDI procedure.

The distal BMAS magnet can be introduced by either swallowable or endoscopic technique: (1) If the patient was physically capable and amenable to the approach, the aptient swallowed the initial magnet (for placement in the distal ileum. Progress of the magnet through the digestive tract was monitored radiologically until it was estimated to have progressed to the ligament of Treitz. This approach eliminated 1 of 2 endoscopic procedures. (2) Alternatively, under anesthesia, the distal magnet may be placed via an endoscopic procedure .

During an inpatient procedure under anaesthesia, using a flexible gastroscope (Olympus America), the distal magnet was delivered to the ligament of Treitz (if unable to swallow) where, using the laparoscopic magnetic delivery device, it was guided intraluminally to the target ileal site 250 to 300 cm from the ileocecal valve. The second (proximal) magnet was transported by gastroscope to the postpyloric duodenum, and nonmagnetic positioning tools were used to elevate the distal ileal magnet over the transverse colon anterior and laterolateral to the proximal duodenal magnet to self-align magnetically. The gastroscope and laparoscopic positioning tools were withdrawn, and the mesenteric defect was closed with running 2-0 silk suture.

Once the individual BMAS magnets are aligned across from one another in the duodenum and ileum, they induce compression and subsequent necrosis of the intervening tissue. Reparative cells gradually infiltrate the tissue at the magnets’ periphery forming a hardware-free anastomosis.

After approximately seven to 21 days, the magnets’ biofragmentable polyglycolic-co-lactic acid flange mechanically degrades, is dislodged from the magnets’ titanium housing and surrounding anastomotic tissue, drops into the intestinal lumen, and is expelled from the body naturally by GI peristalsis for the next 3 to 7 days. After flange fragmentation, the paired magnets’ size is slightly reduced, easing their separation from the anastomosis and passage through the lower digestive tract. The patent duodenoileal anastomosis facilitates flow of alimentary content through both the native duodenojejunal route and the new duodenoileal passage.

On the first postoperative day, abdominal x-ray and fluoroscopy using gastrografin were used to confirm magnet placement. Patients were evaluated within 11 to 17 days of the MagDI procedure and were also required to participate in follow-up visits at approximately days 30, 60, 90, 180, 270, and 360.

Outcomes

The study recruited 15 patients (53.3% female; 100.0% White) between December 2022, and May 2024, who had a mean age of 53.6 ± 1.5 (range 42.0 to 61.0) years. Baseline mean absolute weight was 97.6 ± 2.9 (range 81.0 to 115.0) kg; mean BMI was 33.0 ± 0.4 (range 30.1 to 35.0) kg/m2 (Table 1). All 15 patients had a diagnosis of T2DM and were taking 1 or more diabetes medications at study outset. The mean HbA1C was 8.2% ± 0.4%, and the mean FPG was 187.9 ± 15.5 mg/dL. Fourteen patients reached the 90-day feasibility timepoint, and 8 of 15 (53.3%) patients reached the 180- and 360-day timepoints.

Each patient underwent successful BMAS MagDI with correct placement of both magnets, after a mean operative time of 51.3 ± 5.3 (range 25.0 to 105.0) minutes. The mean hospital stay was 1.0 ± 0.0 days and magnet expulsion occurred at a median of 25.0 days.

Fifty-seven AEs were reported during the course of the study, most of which were anticipated with intestinal bipartition procedures (eg GI symptoms, nutritional deficiencies). The majority of AEs (51 of 57, 89.4%) were classified as mild, CD grade 1 to 2. Three AEs (7.6%) were found to be related to the BMAS device. There were no deaths. At one year, they found that in 100% of patients, anastomoses were fully patent and durable at six-month and one-year follow-up (eight patients with complete data.

Group mean absolute weight fell from 97.6 ± 2.9 kg at baseline to 90.2 ± 3.4 kg at day 90 (p<0.001) and to 88.1 ± 4.4 at day 360 (p<0.001); baseline BMI fell from 33.0 ± 0.4 to 30.1 ± 0.9 kg/m2 (p<0.001) at 1 year. Respective mean EWL and TWL at day 180 were 43.7% ± 12.0% and 9.7% ± 2.1% (8; 53.3%); 6 of 8 (75.0%) of these patients achieved >5.0% TWL. This result (75.0%) held constant at one-year follow-up .

Mean HbA1C decreased from 8.2% ± 0.4% at baseline to 6.6% ± 0.3% (p < 0.05) at 90-day follow-up (14 of 15; 93.3%); FPG fell from 187.9 ± 15.5 to 129.0 ± 5.9 mg/dL (p<0.05). Mean HbA1C and FPG levels remained significantly reduced at one-year follow-up at 6.6% ± 0.1% and 142.8 ± 9.5 mg/dL, respectively (p<0.05). Thirteen percent of patients (2 of 15) stopped their diabetes medications by nine months and have remained off medications; 7 of 15 (46.7%) reduced T2DM medications postoperatively.

“The BMAS in the MagDI procedure is still investigational and requires further research that directly compares its safety and efficacy to that of conventional anastomosis-formation technique,” the study authors concluded. “In early study outcomes, patients with mild obesity and T2D benefitted from the solo MagDI procedure. The intervention was straightforward and feasible to perform and was safe, left no foreign materials in the body, and incurred no severe complications.”

The findings were reported in the paper, ‘First-in-Human Side-to-Side Duodenoileal Bipartition for Weight Loss and Type 2 Diabetes with the Swallowable Biofragmentable Magnetic Anastomosis System’, published in the Journal of the American College of Surgeons. To access this paper, please click here