BACKGROUND: A feasibility study was undertaken with a new treatment for gastroesophageal reflux disease (GERD) that emulates surgical fundoplications and recreates the anti-reflux barrier by forming a one-way gastroesophageal valve. This new endoluminal fundoplication technique involves inserting the EsophyXTM device transorally with the goal of creating a 3–5cm, 180–270 circumference Valve by delivering multiple fasteners under direct visualization by an endoscope. The feasibility and safety of this technique was evaluated in pigs.
METHOD: Eight 40-kg pigs were conducted using the EsophyXTM under general anesthesia. Each procedure were placed five fasteners, one in the middle, two in the corner and two between them. Preoperative endoscopies were performed to assess the anatomy and location of the GEJ before and after fundoplication.
CONCLUSION: EFL procedure allows the creation of an endoluminal fundoplication similar to the endoscopic aspect of a laparoscopic partial fundoplication. The results of the laboratorial testing indicated that the EsophyXTM device was shown to be safe, and capable of deploying fasteners directly into tissue and forming an interrupted suture line at the base of the gastro-esophageal valve (GEV).
The procedure is easy to perform, with no intraoperative complications in pigs. Long-term studies are needed to assess the durability of this new endoscopic technique.
Program Number: P268