Apollo Endosurgery Receives FDA breakthrough device designation for the Orbera intragastric balloon for treatment of patients with NASH

Apollo Endosurgery

1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for the Orbera intragastric balloon, specifically for the indication for use in treating patients with BMI between 30-40 kg/m2 with non-cirrhotic non-alcoholic steatohepatitis with liver fibrosis.

The Mayo Clinic IDE-approved (G160077) study was explicitly designed to evaluate the effects of Orbera placement on metabolic and histologic features of non-alcoholic steatohepatitis, including NAS (indicative of resolution of fat and inflammation in the liver) and fibrosis score.

Read Apollo Endosurgery press release

Michael Wonder

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Michael Wonder