EndoStim has obtained 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 utilising low energy electrical pulses, the EndoStim system strengthens a weak or dysfunctional lower esophageal sphincter (LES) muscle, which is the underlying cause of GERD.
The CE approval is based on a multicentre trial, conducted in Santiago, Chile, designed to demonstrate the safety and efficacy of LES stimulation system.
The results demonstrated improvement in acid reflux while allowing for normal esophageal functions, such as swallowing and belching, as well as day and night time improvement in heartburn symptoms and regurgitation.
The data also indicates 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.
University of South Florida digestive diseases and nutrition division director and professor of medicine Dr Joel Richter said EndoStim LES stimulation technology has the ability to correct GERD pathophysiology, normalising or improving esophageal acid exposure.
"Safety and lack of side effects with this technology makes it an attractive option for patients looking for alternatives to traditional medical therapy," Richter said.
University Medical Centre gastroenterology director and professor of medicine, Professor Peter D Siersema said; "With its ability to personalise 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 ‘Centres of Excellence’ offering EndoStim treatment for the millions of GERD sufferers worldwide."
The company has begun patient enrolment in a commercial registry study and is planning for a US study to begin in late 2013.