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EndoStim receives CE mark approval for full body MRI of patients with its LES stimulation system

Medical device firm EndoStim has received CE mark approval for full body magnetic resonance imaging (MRI) of patients with EndoStim II lower esophageal sphincter (LES) system.

Endo

In May this year, EndoStim received CE mark approval for EndoStim II to treat gastroesophageal reflux disease (GERD).

The latest approval is said to include compatibility with full body MRI scans using 3.0 Tesla MRI machines, while imaging of the head and extremities will continue to be carried out using both 1.5-Tesla and 3-Tesla systems.

The updated recommendations are applicable for both current and future patients with the EndoStim II system.

According to the firm, around 75% of patients could be indicated for an MRI scan over the lifetime of the device.

EndoStim chief medical officer Virender Sharma said: "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.

"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."

GERD is a chronic disease that affects hundreds of millions of patients across the globe and requires lifelong treatment with acid blocker medications.


Image: EndoStim LES stimulation therapy for GERD. Photo: courtesy of PRNewswire, EndoStim.