NIJMEGEN, Netherlands, Oct. 20, 2015 /PRNewswire/ — EndoStim, a medical device company that has developed neurostimulation therapy for gastroesophageal reflux disease (GERD), announced CE Mark approval for a significant expansion of options for Magnetic Resonance Imaging (MRI) use by patients who have the EndoStim II System.
The approval includes compatibility with full body MRI scans using 3.0 Tesla MRI machines. Imaging of the head and extremities may also continue to be performed using both 1.5-Tesla and 3-Tesla systems.
The updated recommendations apply for both current and future patients with the EndoStim II system. Patients and physicians are advised to consult the latest product manual for full guidance on MRI and other imaging systems.
Up to 75% of patients could be indicated for an MRI scan over the lifetime of the device. “We are pleased that EndoStim patients will have access to state-of-the-art 3-Tesla MRI scanners for imaging on any part of their body,” commented Virender K Sharma, EndoStim’s Chief Medical Officer. “MRI scans are commonly used for diagnosis of neurological and orthopedic conditions, and it is important that our patients are able to safely undergo MRI scans for any indication and not be denied this important diagnostic technology.”
“We are proud to be one of the first implantable neurostimulators to achieve compatibility with 3-Tesla MRI systems,” added Paul Goode, EndoStim’s Chief Technology Officer.
For the latest guidance on use of MRI with the EndoStim and EndoStim II systems, visit www.endostim.com/mri.
EndoStim is a medical device company based in St. Louis, Missouri, and Nijmegen, the Netherlands.
EndoStim’s neurostimulation therapy is a minimally-invasive, long-term treatment for severe reflux patients that directly targets the patient’s weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus – often the underlying cause of reflux.
The EndoStim system is CE Marked for patients with gastro-esophageal reflux disease with symptom duration of 6 months or longer, and is available in a number of countries throughout Europe, Latin America, and Asia Pacific. The EndoStim system is not approved for sale in the US and is limited by US federal law to investigational use only.
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 and can lead to Barrett’s esophagus and esophageal cancer. Millions of patients continue to suffer from bothersome GERD symptoms despite maximal medical therapy.