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.
The CE mark approval is based on multicenter trial, conducted in Santiago, Chile, to demonstrate the safety and efficacy of 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 nighttime 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 normalization or greater than 50% reduction in abnormal esophageal acid exposure.
University Medical Center gastroenterology director and ongoing EndoStim international multicenter trial principal investigator Peter D Siersema said, "With its ability to personalize treatment to an individual patient's condition, and with its excellent safety profile, EndoStim therapy could become the ideal option for reflux patients unsatisfied or unhappy with daily medications."
EndoStim president and CEO Bevil Hogg said, "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."
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.
