Apollo Endosurgery picked up a CE mark for its weight-loss balloon, which is designed to remain in the stomach for 12 months, twice as long as its FDA-approved predecessor.
Weight-loss balloons, just one type of weight-loss device approved in the U.S., take up space in the stomach so patients feel full and eat less. Apollo’s Orbera system is delivered to the stomach via endoscope while the patient is sedated and is then inflated with saline. After six months, the balloon is deflated and removed endoscopically. It is FDA-approved to help adults with a body mass index of 30 to 40 lose and maintain weight.
Orbera’s follow-up, the Orbera365 Managed Weight Loss System stays in the stomach for 12 months, doubling treatment time.
“Now with Orbera365 patients will have the possibility of getting better weight loss results because in my experience the longer the treatment the more weight patients tend to lose,” said Alfredo Genco of Sapienza University in Rome, in a statement.
“[Using] Orbera365 our patients will now have twice as long to change their eating behaviors and ensure long lasting results,” Genco said.
The CE mark comes after the FDA renewed its warning on gastric balloons for obesity treatment. Early last month, the agency drew attention to five new reports of patient deaths—four of the patients were being treated with the Orbera system, while the fifth was implanted with ReShape Medical’s Integrated Dual Balloon System.
The FDA originally warned healthcare providers in February to be on the lookout for two types of adverse events in patients who have been implanted with these devices: spontaneous inflation of the balloon and acute pancreatitis.