In Vivo Assessment of a Biological Occluder for NOTES Gastrotomy Closure

Background: The objective of this study is to evaluate the closure of a transgastric natural orifice transluminal endoscopic surgery (NOTES) access using a multilayer extracellular matrix (ECM) occluder in a canine model. Materials and Methods: Mongrel dogs (n = 4) underwent a transgastric NOTES peritoneoscopy and the gastrotomy was closed by deploying a 2-sided ECM occluder. Animals were killed at 7 days (n = 2) and 8 weeks (n = 2) for macroscopic and microscopic assessment. Results: All procedures were completed without any complications. No air leaks were detected immediately after the procedure and at 48 hours postoperatively. At 7 days, ECM appeared to be resolved and mild mucosal inflammation was found at the site of gastrotomy. At 8 weeks, the gastrotomy site was macroscopically and microscopically covered with a normal-appearing gastric mucosa. There was an absence of inflammatory cells and no evidence of the ECM. Conclusion: The ECM occluder is safe and effective in this proof-of-concept preclinical model.