The pre-submission meeting comes in advance of a premarket approval (PMA) submission for the system. Santa Ana, California-based EndoStim designed it to treat drug-refractory gastroesophageal reflux disease (GERD).
EndoStim received FDA breakthrough device designation for the system in October 2022. The 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.
EndoStim initiated the pre-submission request with the FDA following its breakthrough nod. The company said in a news release that the agency provided “constructive feedback” for its regulatory plans. It expects to use the feedback and file its PMA submission this year.
“We appreciate the productive and collaborative meeting with the FDA and found their feedback to be invaluable as we advance the EndoStim System toward regulatory approval,” said Eric Goorno, EndoStim president and CEO. “We’re looking forward to our submission with the intent of bringing this breakthrough technology to U.S. clinicians and their patients who need new treatment options for drug-refractory GERD.”
