Medical device firm EndoStim has received CE mark approval for its second generation lower esophageal sphincter (LES) stimulation system, EndoStim II, to treat gastroesophageal reflux disease (GERD).
GERD is a chronic disease that affects hundreds of millions of patients across the globe and requires lifelong treatment with acid blocker medications.
EndoStim noted that its minimally-invasive therapy for severe reflux is indicated for patients with chronic GERD with symptom duration of six months or longer.
The new device features enhanced MRI conditional compatibility for head and extremity imaging procedures, providing support for 3T MRI machines in addition to the 1.5T MRI machines.
EndoStim chief technology officer Paul Goode said: "It is our goal to continue innovation on the device as well as the therapy to fulfill the needs of patients searching for more optimal long-term solutions for their reflux."
With the approval, the company is making the device available for customers in select European markets.
The EndoStim system is not commercially available for sale in the US and is limited by the US federal law to investigational use only.
Image: EndoStim II LES stimulator for GERD. Photo: courtesy of PRNewsFoto/EndoStim.