Endonetics gets US okay for Gatekeeper trial:
This article was originally published in Clinica
Executive Summary
The US FDA has given Endonetics the go-ahead to begin a multicentre clinical trial of its endoscopic, reflux repair system in patients with gastroesophageal reflux disease (GERD). The Gatekeeper system will allow doctors to perform an outpatient, anti-reflux procedure in 60 minutes or less, claims its San Diego, California manufacturer. GERD, along with its major symptom, heartburn, is the most common disorder of the oesophagus, affecting around 75 million adults intermittently and 19 million on a daily basis in the US alone, says the company.