Background

The objective was to evaluate a new design of magnetic compression anastomosis device for gastrojejunostomy and determine the safety and efficacy at 6 weeks using a swine model. Methods: Using 8 domestic farm female pigs, aged 3-6 months and weighing 55.5-79.2 kg. After the procedure, animals were observed for approximately 6 Weeks (41-46 days) and follow-up radiographs were performed 3 times per week (every single or 3 days) starting 7 days post-implantation to track the movement of the device through the intestines. The proximal magnet was delivered to the stomach using a gastroscope and a delivery catheter. The distal magnet was delivered to the jejunum via laparoscopy. Results: Anastomotic dislodgement occurred between 10 to 26 days and expulsion from 16 to 31 days. In all animals, the magnetic anastomosis devices successfully induced patent anastomoses at 6 weeks post-operatively seen at final gastroscopy and necropsy. Microscopically, 6 weeks postoperatively, the magnetic devices appeared to induce anastomosis with minimal inflammation. This contrasts with suture implantation, which was associated with a much higher degree of injury, inflammatory response and disruption of the mucosal and serosal integrity. In summary, the use of magnetic anastomosis devices to induce a gastrojejunostomy was associated with a good healing response, successfully induced patent anastomosis and was well tolerated clinically with no abnormal clinical signs related to the use of the magnetic anastomosis device.