Gastro-esophageal reflux disease system wins CE mark
Published date : 20 August 2012
Article date : 20 August 2012
EndoStim has received CE mark approval for its LES Stimulation system, designed to treat gastro-esophageal reflux disease (GERD) and eliminate the need for daily proton pump inhibitor (PPI) medication. By using low energy electrical pulses, the EndoStim system will strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle, which is the underlying cause of GERD.
EndoStim has received CE mark approval for its LES Stimulation system, designed to treat gastro-esophageal reflux disease and eliminate the need for daily proton pump inhibitor medication. By using low energy electrical pulses, the device will strengthen a weak or dysfunctional lower esophageal sphincter muscle which is the underlying cause of GERD.
The CE mark approval is based on a multicenter trial, conducted in Santiago, Chile, to demonstrate the safety and efficacy of the LES Stimulation system. The results demonstrated improvement in acid reflux while allowing for normal esophageal function such as swallowing and belching as well as both daytime and night time improvement in heartburn symptoms and regurgitation. The 12 months data also indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI, while 77% achieved normalisation or greater than 50% reduction in abnormal esophageal acid exposure.
The company said it has begun enrollment patients in a commercial registry study and is planning for a US study to begin in late 2013.
Source: MDBR Staff Writer, MDBR Edoscopy Devices, 20 August 2012 (U.S.)
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