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 pat…