EndoStim’s LES Stimulation System Gets CE Mark for MRI Use

EndoStim’s Lower Esophageal Sphincter (LES) Stimulation System is now cleared for use in the CE Mark countries with MRI scans of the head and extremities, the Dutch devicemaker said this month. The system is indicated for patients with gastroesophageal reflux disease with symptom duration of six months or longer.

According to the company, the system helps patients with severe acid reflux and/or esophageal reflux disease get treatment without relying on daily medications. It was tested for use with a 1.5 Tesla MRI machine using a transmit/receive RF local coil, the company says, allowing patients with the implanted system to be diagnosed with neurological or orthopedic conditions, if necessary.

The stimulator and butterfly-shaped implantable leads are implanted laparoscopically into the lower esophagus and abdominal pocket, respectively, where they deliver electrical pulses to the weakened esophageal sphincter causing the severe acid reflux, EndoStim says. Its implantable pulse generator communicates wirelessly with the programmer and can be adjusted to account for differing levels of reflux control on different days or at different times.

EndoStim’s system has had CE Marking in the European Economic Area since August 2012 without the MRI clearance. It is also approved in Australia, Argentina and Colombia and has been used in Hong Kong, New Zealand, Chile and India. — Lena Freund

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