EP906 - The GI Windows Flexagon™ Magnetic Compression Technology; A Novel Technique In Bowel Anastomosis

Purpose/Background: One of the most common procedures performed by Colorectal surgeons involves the resection and anastomosis of two pieces of bowel. Though there are a variety of ways to accomplish this, universally accepted techniques generally fit into two categories: hand-sewn or stapled. While these techniques are tried and true, room exists for improvement and innovation. Furthermore, with the increased adoption of minimally invasive surgery, these methods can present additional challenges. For example, laparoscopic suturing has a steep learning curve, and colorectal end-to-end anastomoses during robotic surgery can require extracorporeal anvil placement in the proximal colon, which results in the surgeon needing to leave the console and scrub back into the case, which can prolong operative time. The GI Windows Flexagon™ magnetic compression technology employs two rings of self-forming magnets (SFMs) which seal the two opposing ends of bowel together. When combined with the GI Windows OTOLoc™ technology, the system creates a sealed compression anastomosis which allows for immediate flow of enteric contents with no need for closure of enterotomies or the common channel. As the magnets fuse circumferentially between the two limbs of bowel, a compression anastomosis is created with the OTOLoc and Flexagon SFM devices eventually passing per rectum, leaving no foreign material in the anastomosis. Previous studies in our group have focused on foregut or small to large intestinal anastomosis. This is the first study using the Flexagon SFM and OTOLoc system to evaluate the feasibility of a magnetic compression technique for colorectal anastomosis.

Methods/Interventions: This preclinical study assessed the feasibility of using a magnetic compression anastomosis technique after a simulated Low Anterior Resection (LAR). 10 LARs were performed with magnetic compression anastomosis (MCA) on standard, female Yorkshire pigs, with either a fully laparoscopic anastomosis (n=5) or an anastomosis using natural orifice access (n=5). There was 1 control animal for gross histology assessment and luminal diameter, performed with a 28 EEA. All animals survived with no post-operative complications and were sacrificed at the planned 14-day in-vivo period in either treatment of controlled arm. Outcomes included ability to perform the magnetic anastomosis, time to passage of the SFM and OTOLoc, post-operative survival, anastomotic complications, and any adverse events.

Results/Outcomes: All 10 anastomoses were successfully completed using the GI Windows SFM and OTOLoc technologies. All implanted devices passed thru the rectum without complication between 7-14 days after surgery. All 11 pigs survived the planned 14 day in-vivo period without further intervention, and there were no adverse events recorded. Before being sacrificed, the pigs underwent endoscopic evaluation, which showed no anastomotic complications, including bleeding, leak, or stricturing. Although the control group was limited to a single pig, it provided a valuable baseline for comparison in histological appearance and luminal diameter. Compared to the control, the treatment animals demonstrated equivalent or superior anastomotic integrity, with no evidence of adverse histologic or functional outcomes.

Conclusion/Discussion: This preclinical study indicates that magnetic compression colorectal anastomosis is feasible, safe and efficacious. Further investigation including trials in humans are needed to confirm these findings.