FDA backs EndoStim’s neurostimulation implant for GERD control
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The FDA has granted breakthrough device designation to EndoStim for its implantable device which serves as a treatment option for patients with refractory gastroesophageal reflux disease, according to a manufacturer release.
The EndoStim System is a neurostimulation device which is implanted laparoscopically and designed to provide long-term reflux control via automatically delivered mild electrical signals to the lower esophageal sphincter throughout the day. Programmed wirelessly by the physician, the system “automatically stimulates” the lower esophageal sphincter without any sensation to the patient, allowing the muscle to function normally.
“We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” Eric Goorno, CEO of EndoStim, said in the release. “Our goal is to bring this new therapy to patients as quickly as possible. We look forward to working closely with the FDA to expedite the review of the
EndoStim System.”