Hogan Lovells advises Apollo Endosurgery in securing FDA market authorization for Endoscopic Sleeve Gastroplasty (ESG) and endoscopic bariatric revision devices

Washington, D.C., 9 September 2022 — Global law firm Hogan Lovells advised Apollo Endosurgery, Inc., a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, in securing market authorization of the Apollo ESGTM, Apollo ESG SxTM, Apollo REVISETM and Apollo REVISE SxTM Systems through the U.S. Food and Drug Administration's (FDA) De Novo Reclassification process.

Authorization was granted based on the results of a randomized controlled trial demonstrating safety and effectiveness of the endoscopic sleeve gastroplasty (ESG) procedure for weight loss over a two-year period.  Real-world evidence from a literature review, multiple case series, and registries were used to further support data for the ESG and Transoral Outlet Reduction (TORe) bariatric revision procedures. These are the first and only devices authorized by FDA for ESG and endoscopic bariatric revision. Further details of the grant of the De Novo submission can be found here.

The Hogan Lovells team was led by Medical Device and Technology Group partners Jonathan Kahan and Kristin Zielinski Duggan, senior associate Suzanne Levy Friedman, and associate Sanchita Bose (all Washington, D.C.). 

 


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