THE HAGUE, Netherlands―EndoStim B.V. announced today CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD).
The EndoStim system uses low-energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle which is the underlying cause of gastro-esophageal reflux disease (GERD) or acid reflux. EndoStim's device, implanted through a minimally-invasive laparoscopic procedure, is intended to treat acid reflux and eliminate the need for daily PPI medication. In clinical trials the treatment was able to significantly reduce acid exposure and related symptoms of heartburn and regurgitation without causing any gastrointestinal side effects seen with other anti-reflux procedures.
Bevil Hogg, president and CEO of EndoStim, stated, "EndoStim is very excited to offer a truly revolutionary treatment to patients with severe GERD―one that is designed to normalize esophageal function. EndoStim is working closely with leading GERD experts throughout the world to develop 'Centers of Excellence' offering EndoStim treatment for the millions of GERD sufferers worldwide."
Virender Sharma, MD, chief medical officer of EndoStim and director of the Arizona Center for Digestive Health, added, "EndoStim LES stimulation therapy is a result of years of research and development with leading researchers in esophageal diseases in the US and clinical investigators in Europe and South America. EndoStim's long-term clinical data strongly supports the efficacy and safety of its therapy in patients with severe GERD."
According to EndoStim's news release, clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100 percent of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77 percent achieved normalization or greater than 50 percent reduction in abnormal esophageal acid exposure, the company added.