Gastric Balloon Labeling Updated After Patient Deaths
US FDA has approved updated labeling for Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System in the wake of five more patient deaths.
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A letter from the US agency clarifies the risks of over-inflation, acute pancreatitis and death in patients who have been treated with liquid-filled intragastric balloons.
Apollo Endosurgery sold its surgical product line, including the Lap-Band adjustable gastric banding system and other accessories for laparoscopic bariatric surgery, to ReShape Lifesciences for $17m plus other considerations, including the ReShape endoscopic balloon, the companies announced Dec. 18. The deal will allow Apollo to focus on endo-bariatric procedures while it gives ReShape an instant revenue stream and another product to sell to surgeons, its core customers.
Apollo Endosurgery and Reshape Medical are both defending their products’ safety in the wake of a US FDA letter warning of five deaths tied to the companies' intragastric balloon devices.