EndoStim has announced that the EndoStim 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 system can now receive head and extremity MRI scans, often used for diagnosis of neurological and orthopedic conditions.
Both the EndoStim Stimulator and Implantable Lead underwent significant testing to demonstrate that the device does not malfunction nor pose any risk to patients when exposed to a 1.5 Tesla MRI machine using a transmit/receive RF local coil.
Because of its superior diagnostic capabilities, MRI use has increased dramatically in recent years. MRI is among the advanced diagnostic imaging technologies widely credited with earlier and more accurate non-invasive diagnoses of disease.
EndoStim chief medical officer Dr Virender K Sharma said the company is 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," Dr Sharma added.
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, pre-programmed low-energy electrical stimulation therapy is automatically delivered each day to the lower esophageal sphincter (LES) at the junction of the stomach and esophagus.
The stimulation is designed to improve the function of the patient’s weak or dysfunctional LES – often the underlying cause of reflux – resulting in significant improvement in 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.