V12-02: MAGNETIC BOWEL ANASTOMOSIS: FIRST-IN-HUMAN MAGNAMOSIS APPLICATION
Bowel anastomosis is a critical component of the development and performance of many complex urologic procedures. Traditional anastomoses are hand-sewn, but staplers have become more commonplace, shortening procedure time and increasing uniformity. However, both methods leave foreign bodies at the site, which can interfere with healing and cause inflammation and stricture. Staplers increase procedure cost, suffer from device malfunction, and are limited in usage due to device size. Magnamosis is a novel device for the creation of compression anastomosis consisting of two self-aligning, symmetric magnetic rings covered in a polycarbonate casing. The device&[prime]s unique geometry creates a gradient of compression, which promotes necrosis and lumen formation centrally, while allowing for tissue remodeling and healing at the periphery. We have studied the device in over 70 pigs and 10 monkeys, all with excellent results, including burst pressures that were similar to or better than hand-sewn or stapled techniques. We have obtained an FDA Investigational Device Exemption to perform magnetic anastomosis in 10 human subjects to ensure safety and efficacy of the device, and we now report our experience with our first procedure. _x000D_
We performed the first-in-human Magnamosis in a 28 year-old male with neurogenic bladder undergoing creation of a continent catheterizable ileal channel. The 23mm magnets were placed through small ileal enterotomies and arranged in parallel for a side-to-side, functional end-to-end, isoperistaltic configuration. Our technique is further demonstrated in the accompanying video.
The patient tolerated the procedure well with no adverse events. He was restarted on his home bowel regimen post-operatively and resumed bowel function on post-op day 3. The progress of the magnets was followed with serial abdominal x-rays until their uneventful evacuation.
We report the first-in-human application of the Magnamosis device for magnetic compression anastomosis. Though demonstrated here in open bowel anastomosis, the device has the ability to be deployed using laparoscopic, endoscopic, radiographic, or hybrid techniques in a variety of sizes. This scalable technology can be adapted to a variety of luminal anastomoses, with wide-reaching implications for the future of reconstructive surgery.
Funding: FDA Pediatric Device Consortia Program_x000D_ NSF Emerging Frontiers in Research and Innovation (EFRI) Program_x000D_ UCSF Department of Surgery