Medtronic tests endoscopic GERD (gastroesophageal reflux disease) therapy in US trial:
This article was originally published in Clinica
Medtronic has started a pivotal US trial of its endoscopic treatment for gastroesophageal reflux disease (GERD), a condition that affects 21 million Americans. The Gatekeeper reflux repair system, already approved in Europe, is designed to reduce the symptoms associated with GERD through the use of prostheses that mimic the normal functioning barrier between the stomach and the oesophagus. The US trial will include 144 patients. Importantly, Medtronic says, it is the first clinical trial of an endoscopic therapy to treat GERD that will measure the placebo effect before the product is submitted to the FDA.