Claire E Graves, MD, Ryan S Hsi, MD, Selma Masic, MD, Jill Imamura-Ching, RN, Marshall L Stoller, MD, Michael R Harrison, MD. University of California, San Francisco
Objective: Bowel anastomosis is a critical component of many surgical procedures. Currently, most anastomoses are hand-sewn or stapled. However, both methods have significant drawbacks. Hand-sewn anastomoses are time-intensive and allow for human variation and error, while staplers are expensive and suffer from device malfunction. Moreover, both methods are poorly suited for minimally invasive techniques. With Magnamosis, we have developed a mechanism for creating reliable, well-formed bowel anastomoses that is amenable to laparoscopic, endoscopic, radiologic, or hybrid minimally invasive procedures.
Description of technology and method of use: Magnamosis is a novel device for the creation of compression anastomosis consisting of two self-aligning, symmetric magnetic rings encased in a specially-engineered polycarbonate casing. The device’s unique geometry creates a gradient of compression, which causes necrosis and lumen formation centrally, while allowing for tissue remodeling and healing at the periphery. We have previously 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 first-in-human procedure.
We performed magnetic compression anastomosis with Magnamosis in a 28 year-old male with neurogenic bladder undergoing open creation of a continent catheterizable ileal channel. The magnets were placed through ileal enterotomies, and the two ends of intestine were arranged in parallel for a side-to-side, functional end-to-end, isoperistaltic configuration.
Results: The patient tolerated the procedure well with no adverse events, and his postoperative course was uneventful. He resumed bowel function on post-operative day 3. The progress of the magnets was followed with serial abdominal x-rays until their uneventful evacuation.
Conclusions: We report the first-in-human application of the Magnamosis device for magnetic compression anastomosis and are actively recruiting to complete our Phase I trial. Though demonstrated here in open bowel anastomosis, the device has the ability to be deployed using laparoscopic, endoscopic, radiographic, or hybrid techniques in multiple sizes. This scalable technology can be adapted to a variety of intra-luminal anastomoses, including intestinal, urologic, and biliary applications, with wide-reaching implications for the future of minimally invasive surgery.
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