A Novel Revolutionary Surgical Device for TransOral Incisionless Surgery: EsophyX™ Used for Endoluminal Fundoplication (ELF) in Patients Suffering of Reflux Disease

Summary form only given: A huge revolutionary step toward surgery with no incisions, through natural orifices has been done in last two years. The novel endoluminal fundoplication (ELF) technique using a Trans-Oral Incisionless and fastener-deploying device (EsophyXtrade, EndoGastric Solutions) was developed and evaluated for feasibility, safety and the treatment of gastro-esophageal reflux disease (GERD) in a series of animal and human (phase 1, phase 2) studies. The studies verified biological compatibility, durability and non-toxicity of the polypropylene fasteners as well as the feasibility of the ELF technique. The results of the preclinical testing indicated that the EsophyXtrade 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 clinical studies demonstrated also that the ELF technique performed using the EsophyXtrade device resulted in the creation of new gastro esophageal valve of 3-5 cm in length and a circumference of 200deg-310deg, which maintained their anatomical aspects at 2 years. The ELF-created GEVs appeared similar to those created by laparoscopic anti- reflux surgery (LARS). The ELF procedure also resulted in reduction of all small hiatal hernias (2 cm in size) and restoration of the angle of His, providing an anatomical approach similar to that of LARS for the treatment of GERD. Our work shows that that at 24 months follow up more than 80% of the subjects no longer had heartburn, or regurgitation, needed PPIs and almost 70% had normal or clinically improved esophageal acid exposure. The paper presents the new incisionless surgical technique and approach.