Magnetic Compression Anastomosis (Magnamosis): First-In-Human Trial.

ABSTRACT

BACKGROUND: Magnetic compression anastomosis (magnamosis) uses a pair of self-centering magnetic Harrison Rings to create an intestinal anastomosis without sutures or staples. We report the first-in-human case series using this unique device. STUDY DESIGN: We conducted a prospective, single-center, first-in-human pilot trial to evaluate the feasibility and safety of creating an intestinal anastomosis using the Magnamosis device. Adult patients requiring any intestinal anastomosis to restore bowel continuity were eligible for inclusion. For each procedure, 1 Harrison Ring was placed in the lumen of each intestinal segment. The rings were brought together and mated, and left to form a side to side, functional end to end anastomosis. Device movement was monitored with serial x-rays until it was passed in the stool. Patients were monitored for adverse effects with routine clinic appointments, as well as questionnaires. RESULTS: Five patients have undergone small bowel anastomosis with the Magnamosis device. All 5 patients had severe systemic disease and underwent complex open urinary reconstruction procedures, with the device used to restore small bowel continuity after isolation of an ileal segment. All devices passed without obstruction or pain. No patients have had any complications related to their anastomosis, including anastomotic leaks, bleeding, or stricture at median follow-up of 13 months. CONCLUSIONS: In this initial case series from the first-in-human trial of the Magnamosis device, the device was successfully placed and effectively formed a side to side, functional end to end small bowel anastomosis in all 5 patients. No patients have had any anastomotic complications at intermediate follow-up.