EndoStim prepares FDA PMA submission for neurostim implant that treats GERD

[Image courtesy of EndoStim]EndoStim announced today that it held a pre-submission meeting with the FDA regarding its implantable neurostimulation treatment for GERD.

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…

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