A Novel Therapeutic Method in Gastro-esophageal Reflux Disease.

Abstract

Gastro-esophageal reflux disease (GERD/GORD) is a chronic condition in which gastric acid flows backwards up into the esophagus, causing heart burn and a higher disposition to esophageal cancer. The reflux is caused by impairment of the lower esophageal sphincter (LES). Over the past century gastro-esophageal reflux has become the principal gastrointestinal condition of our time. The proton pump inhibitor class of drugs is effective in ameliorating the symptoms of reflux. The cost of investigation of patients in Europe is €100 billion per annum. The cost in days lost from work is €100 billion per annum in Europe. The global cost is 3 times this amount. The proposed device for treating gastro-esophageal reflux is a biodegradable valve that is placed non surgically in the esophago-gastric junction to prevent reflux from the stomach to the esophagus. 50 simulator studies were performed with the patented device to elucidate the most consistent method of insertion and fixation in a human like simulator. The simulator was designed to replicate the normal human gastro-esophageal anatomy and characteristics. Four animal insertions were performed under ethical regulation at Amsterdam Medical Centre, Netherlands. Three cadaveric experiments were performed at Hackensack University Hospital, New Jersey, USA, to verify the positive outcomes of the simulator studies. Successful outcomes of simulator studies and cadaveric experiments allowed the design freeze of a NoReflux device for treating gastro-esophageal reflux disease.