Lower Esophageal Sphincter Stimulation System Receives CE Marking for MRI Scanning

A lower esophageal sphincter (LES) stimulation system has received CE marking for use with magnetic resonance imaging (MRI), and is now conditionally approved for MRI scans of head and extremities.

Current and future patients with the EndoStim (The Hague, The Netherlands, and St. Louis MO, USA) stimulation system can now receive head and extremity MRI scans, often used for diagnosis of neurologic and orthopedic disorders. Both the EndoStim stimulator and implantable lead underwent significant evaluation to demonstrate that the device does not malfunction nor present any risk to patients when exposed to a 1.5 Tesla MRI scanner using a transmit/receive radiofrequency (RF) local coil.

Because of its superior diagnostic capabilities, MRI use has increased dramatically in recent years. “We are happy to see the safety of the EndoStim system with MRI confirmed. From now on current and future patients who seek EndoStim’s minimally invasive solution for severe reflux can safely undergo head and limb MRI scans and not be deprived of the superior diagnostic advantage of this test,” stated Dr. Virender K Sharma, EndoStim’s chief medical officer.

EndoStim’s LES stimulation therapy is a minimally-invasive, long-term treatment for severe reflux patients who are unsatisfied with their medical therapy. After a simple laparoscopic procedure to place the EndoStim device, preprogrammed low-energy electrical stimulation therapy is automatically delivered each day to the lower esophageal sphincter at the junction of the stomach and esophagus. The stimulation is designed to improve the function of the patient’s weak or dysfunctional LES, frequently the underlying cause of reflux, resulting in substantial improvement in gastroesophageal reflux disease (GERD) symptoms of both heartburn and regurgitation, improvement in esophageal acid exposure and resulting damage and elimination of dependence on daily medications in most patients.

The EndoStim system is not yet approved for sale in the United States and is limited by US federal law to investigational use only.

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