Apollo Endosurgery Endoscopic Devices Get De Novo Marketing Authorization

Austin, Texas-based Apollo Endosurgery has received De Novo marketing authorization from the FDA for its Apollo ESG, Apollo ESG Sx, Apollo Revise and Apollo Revise Sx endoscopic devices for treatment of obesity.

The devices are specifically for use in endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision surgeries for weight loss.

Currently, less than 0.2 percent of adults with obesity are treated surgically for obesity, leaving a substantial unmet need, the company said.

The De Novo authorization pathway is for low-to moderate-risk devices without an already approved, cleared or authorized reference product. De Novo devices are those for which general and special controls provide a reasonable assurance of the device's safety and effectiveness.