Santa Ana, California-based EndoStim designed its system to treat drug-refractory gastroesophageal reflux disease (GERD). The disease affects the ring of muscle between the esophagus and the stomach, the lower esophageal sphincter (LES). It causes stomach acid to repeatedly flow back into the esophagus. The backwash (acid reflux) can irritate the lining of the esophagus.
EndoStim’s system features an implantable neurostimulation device and lead, placed in a quick, minimally invasive laparoscopic procedure.
The company developed its system to provide long-term reflux control. It automatically delivers mild electrical signals throughout the day to the patient’s week or dysfunctional LES muscle. A physician programs the EndoStim system wirelessly using a handheld controller. It automatically stimulates the LES to allow it to function normally without any sensation to the patient.
“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,” said Eric Goorno, CEO. “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.”