US-based EndoStim has obtained CE Mark approval for its lower esophageal sphincter (LES) stimulation system to use with magnetic resonance imaging (MRI).
This new approval allows current and future patients with the EndoStim system to safely undergo head and limb MRI scans, often used for diagnosis of neurological and orthopaedic conditions.
In addition, both the EndoStim stimulator and implantable lead underwent a series of significant testing to demonstrate that the device is safe and does not pose any risk to patients when exposed to a 1.5 Tesla MRI machine using a transmit/receive RF local coil.
In recent years, based on the superior diagnostic capabilities, MRI use has increased dramatically. It is among the advanced diagnostic imaging technologies widely recognised with earlier and more accurate non-invasive diagnoses of disease.
EndoStim's device, implanted through a minimally invasive laparoscopic procedure with electronic leads stretching to the lower esophageal sphincter, is intended to treat severe reflux patients and to eliminate the dependence on daily medications in most patients.
The EndoStim system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle at the junction of the stomach and esophagus, which is the underlying cause of gastro-esophageal reflux disease (GERD) or acid reflux.
EndoStim chief medical officer Dr Virender K Sharma said: "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."
The EndoStim system is currently not approved for sale in the US and is limited by US federal law for investigational use only.
Image: EndoStim LES stimulation system. Photo: courtesy of EndoStim BV/PR Newswire.