Gastric Balloon-Makers Respond To US FDA Warning
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.
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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.
The global market for minimally invasive weight loss devices is expected to grow to $290m by 2021, a CAGR of 16%, driven in large part by the rising obesity epidemic and associated Type 2 diabetes. Meddevicetracker expects that enhancements and innovations, particularly in the growing intragastric balloon market, and emerging technologies by smaller companies, will lead the growth in the overall weight loss devices market. In this feature, we'll take a closer look at the overall market and regional landscape and take a deep dive into the fastest-growing intragastric balloon segment, providing key insights from a bariatric surgeon on the pros and cons of these technologies.
The deal, worth $61m in cash and stock, will add ReShape's Dual Weight Loss Balloon to EnteroMedics' vBloc neurometabolic therapy and Gastric Vest System for the treatment of obesity.