Intragastric balloon to treat obesity. An old friend with new horizons. About The first Spanish device (Stella®).

Abstract

We present the Clinical Trial results of the first Spanish intragastric balloon manufactured: the Stella® balloon (SwanMedical, Barcelona). As a peculiarity, it has a double lumen in the introducer system. The first one is intended for the passage of a guidewire to insert the balloon quickly and safely, which also requires prior gastroscopy. The second lumen allows for regular filling. Therefore, Stella® accepts all current IGB indications, adding specific applicability for endoscopists in training and for some pharyngo-oesophageal anatomical alterations that could make the placement of another IGB model difficult or impossible. In conclusion, preliminary results suggest that Stella® could have efficacy and safety values comparable to those of the leading currently approved intragastric balloons. Final certification and market release of the device is expected by the end of 2024.