www.fdanews.com/articles/183354-apollo-endosurgery-wins-ce-mark-for-12-month-orbera-weight-loss-balloon
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Apollo Endosurgery Wins CE Mark for 12-Month Orbera Weight Loss Balloon
September 5, 2017
Apollo Endosurgery won an expanded CE Mark approval for its Orbera weight loss system, extending the indwell period of the gastric balloon from 6 to 12 months.
The balloon device is designed to be inserted non-surgically in obese patients with body mass indexes of 30 to 40. After insertion, the balloon is inflated to fill space in the stomach.
Apollo Endosurgery said it expects to begin commercialization of the device in the fourth quarter of 2017.