Sam Brusco, Associate Editor10.25.22
EndoStim has gained U.S. Food and Drug Administration (FDA) breakthrough status for its EndoStim implantable neurostimulation system to treat drug refractory gastroesophageal reflux disease (GERD).
The designation aims to provide more timely access to medical devices for more effective treatment/diagnosis of life-threatening or irreversibly debilitation conditions. The status speeds up development, assessment, and review.
"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 told the press. “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.”
The designation aims to provide more timely access to medical devices for more effective treatment/diagnosis of life-threatening or irreversibly debilitation conditions. The status speeds up development, assessment, and review.
"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 told the press. “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.”