In April 2022, the French National Authority for Health (HAS) published the draft opinion on the coverage of the endoscopic gastroplasty with the use of the ENDOMINA triangulation platform from the Endo Tools Therapeutics under the Innovation package (Forfait innovation). However, the HAS provided some recommendations regarding the modification of the study protocol that should be implemented within 30 days. The HAS opinion of April 2022 can be found here.
After the necessary changes were implemented into the protocol, on May 31, 2022, HAS published a final positive opinion on the coverage of the ENDOMINA triangulation platform under the Innovation package (Forfait innovation) with the indication for the type 2 diabetic patients suffering from so-called "moderate" class I obesity (30 ≤ body mass index (BMI) < 35 kg/m2).
More details can be found in French here.
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