The FDA has proposed a benefit-risk assessment system for weight loss devices that would use available safety data for a device to set efficacy thresholds for a pivotal trial of that device. BioCentury reports that the proposal came in briefing documents issued to FDA's Gastroenterology and Urology Devices Panel ahead of a meeting on Thursday and Friday to discuss issues in the development of devices placed endoscopically or laparoscopically.
Devices would be classified into one of three risk levels based on the percent of patients who experience mild, intermediate and severe adverse events over one year. For example, to qualify for the lowest risk category, devices can have high rates of the most mild events (up to 100%), low rates of events of intermediate severity (2-5%), and very low rates of the more severe events (<0.1%).
Each level of risk would set corresponding efficacy endpoint targets for pivotal trials. Targets for the least risky devices would be based on endpoints used for weight loss drugs, while targets for the highest risk devices would be based on the two FDA-approved obesity devices, which the agency said fall into the high risk category. Those are the Lap-Band adjustable gastric banding system from Allergan and the Realize adjustable gastric band from the Ethicon Endo-Surgery.
FDA also proposed that efficacy be measured using percent total body weight loss instead of the current standard of percent excess weight loss. The panel is part of the Medical Devices Advisory Committee.