EndoStim LES Stimulation System Receives CE Marking for MRI Scans

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Apr 18, 2014, 07:00 ET

THE HAGUE, Netherlands and ST. LOUIS, April 18, 2014 /PRNewswire/ -- EndoStim BV 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.

EndoStim(R)LES Stimulation Therapy. (PRNewsFoto/EndoStim) (PRNewsFoto/ENDOSTIM)

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

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.[1]

"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.

About EndoStim Therapy

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.

About Reflux Disease

Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when weakness or dysfunction in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal inflammation and damage. Acid reflux causes heartburn, regurgitation or both and can lead to Barrett esophagus and esophageal cancer. Millions of patients continue to suffer from bothersome GERD symptoms despite maximal medical therapy and many do not want to take long-term medications due to growing concerns of long-term safety with these medications.

About EndoStim

EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and the Hague, the Netherlands.

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

For more information and news about EndoStim, please visit www.endostim.com.

[1] Smith-Bindman R, et al. Use of Diagnostic Imaging Studies and Associated Radiation Exposure For Patients Enrolled in Large Integrated Healthcare Systems, 1996–2010. JAMA. 2012;307(22):2400-9.

Photo - http://photos.prnewswire.com/prnh/20140213/CG64360

SOURCE EndoStim