Magnetic Compression Anastomosis Immediate Luminal Patency in Colorectal SurgeryFirst-in-Human Safety and Feasibility Evaluation of the OTOLoc™ + Flexagon™ System

Purpose/Background: Conventional colorectal anastomoses constructed with sutures or staples require tissue penetration, which may contribute to local ischemia, microabscess formation, and anastomotic leakage. Magnetic compression anastomosis (MCA) offers a non-penetrating alternative for tissue approximation; however, earlier MCA platforms required delayed luminal patency, limiting their applicability in colorectal surgery where immediate bowel continuity is essential.

Methods/Interventions: We conducted a first-in-human, early-phase prospective safety and feasibility study at a tertiary referral center for minimally invasive colorectal surgery. A consecutive series of 25 adult patients undergoing elective laparoscopic or robotic colorectal resection received intracorporeal anastomosis using a novel magnetic compression system (OTOLoc™ + Flexagon™) engineered to maintain immediate luminal patency. Procedures followed a standardized operative protocol. The primary outcome was anastomotic leak within 30 postoperative days. Secondary outcomes included technical feasibility, adverse events, device performance, and anastomotic patency during 60 days of follow-up

Results/Outcomes: All procedures were completed using minimally invasive techniques without conversion to open surgery. Intracorporeal magnetic compression anastomoses were technically successful in all cases. No anastomotic leaks were observed within 30 days. Adverse events occurred in 6 patients (24%), all classified as Clavien-Dindo Grade I and managed conservatively. Postoperative imaging and/or endoscopic evaluation demonstrated complete anastomotic patency and healing in all patients, with no evidence of stenosis, obstruction, or delayed transit during 60 days of follow-up.

Conclusion/Discussion: In this first-in-human experience, intracorporeal colorectal anastomosis using a non-penetrating magnetic compression system with immediate luminal patency was feasible and demonstrated a favorable short-term safety profile. The absence of anastomotic leaks and consistent patency suggest that this technology may represent a biologically distinct approach to anastomotic healing. Although limited by small sample size, single-center design, and lack of a comparator group, these findings support further prospective and comparative studies to define the role of MCA in colorectal surgery.