Global medical device company Apollo Endosurgery has gained Conformité Européene (CE) Mark approval for its ORBERA365 Managed Weight Loss System.
According to the company, the weight loss system is an incision-less, non-surgical weight loss solution for obese patients. In the procedure, a thin and deflated ORBERA365 balloon is placed into the stomach and filled with saline for up to 12 months and is then deflated and removed.
Speaking about the approval, CEO of Apollo Endosurgery, 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 intra-gastric balloon therapy."
He added, "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.”