Netherlands-based device maker EndoStim B.V. won European regulatory approval for its LES Stimulation system, an implantable muscle stimulation device for patients with severe gastro-esophageal reflux disease.
The LES system won CE Mark approval for based on clinical results form a 12-month clinical trial during which 100% of the patients were able to stop their daily drug regimen for managing their disease, according to a press release.
The treatment proved to "significantly reduce acid exposure and related symptoms of heartburn and regurgitation without causing any gastrointestinal side effects seen with other anti-reflux procedures," according to the company.
The device is implanted subcutaneously in the abdomen with leads connecting to the lower esophageal sphincter. The LES system delivers low energy electrical impulses to strengthen a weak or dysfunctional LES muscle, which is the underlying cause of GERD, also known as acid reflux.
The LES system improved both daytime and nighttime symptoms for patients in the clinical trial, without affecting normal esophageal functions such as swallowing or belching, according to the release.
Lead trial investigator Dr. Leonardo Rodriguez called the device "the ideal treatment option for patients with severe GERD who are unhappy with their medical therapy or want freedom from life-long dependence on medications."
EndoStim has begun working on enrollment for a U.S. clinical trial, and expects the study to begin in late 2013.
