Apollo Endosurgery has received CE-Mark for its ORBERA365 Managed Weight Loss System allowing commercialisation in the European Union (EU) and member countries of the European Economic Area.
Designed to help adults suffering from obesity, ORBERA365 is an incisionless, non-surgical weight loss system suitable for patients who are not eligible for an invasive surgery and could not achieve results through diet, exercise or pharmaceutical interventions.
The thin and deflated ORBERA365 balloon is fitted using an endoscopic procedure and later filled with saline until it reaches the size of a grapefruit.
Estimated to take approximately 20 minutes, the procedure is said to enable patients to go home after a few hours.
Apollo Endosurgery CEO Todd Newton said: “The CE-Mark approval of ORBERA365 has been a significant accomplishment for Apollo and involved a comprehensive review of clinical and non-clinical data by a regulatory body in a market with deep understanding and experience with intragastric balloon therapy.
“Obtaining CE-Mark approval now for ORBERA365 is a strong testimony of the relevance and significance of more than a decade of the ORBERA system’s safety and efficacy data as supported by more than 277,000 distributed implants and 230 published peer-reviewed papers.”
The balloon is deflated and removed after about 12 months through another non-surgical procedure.
During this period, the patient works in a formal lifestyle modification programme with a physician and their staff to meet long-term weight loss goals by adapting sustainable and healthy habits.