CE Mark Means Patients with EndoStim LES Can Now Undergo MRI Scans

EndoStim BV has seen its EndoStim LES Stimulation System receive CE Mark approval for use with Magnetic Resonance Imaging (MRI), and is now conditionally approved for MRI scans of head and extremities.

Background

MRI compatibility of implantable electrical devices has been one of the hot topics of the past 12 months or so, as many cardiac pacemaker and ICD-type devices clamour for regulatory nods.

Being able to undergo MRI scans offers clear patient benefits for diagnosis of neurological and orthopedic conditions. People suffering from severe refluxing are no less likely than the rest of us to require the superior diagnostic capabilities delivered by MRI scanning. Now that Endostim’s LES (Lower Esophageal Sphincter) device has been CE mark approved for its compatibility with MRI scans, at least of the head and extremities, this means patients fitted with the device retain this important diagnostic possibility.

Endostim’s LES represents 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.

Endostim’s 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, used as described in detail at www.endostim.com/mri.

Company comments

“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,” states Dr. Virender K Sharma, EndoStim’s Chief Medical Officer.

Source: EndoStim BV, PR Newswire

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