FDA Weighs Patients' Risk Tolerance in Approving Obesity Device
This article was originally published in The Pink Sheet Daily
The agency approved EnteroMedics’ Maestro neuromodulator to treat obesity despite the device not meeting endpoints in its pivotal trial. The agency relied in part on a survey that found obese patients willing to take more risks in exchange for weight loss.
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A pilot study that explored how much risk patients would be willing to tolerate from a device implant in order to achieve significant weight loss is helping CDRH regulators understand how to accurately and reliably measure patient preferences. The goal is to start incorporating those preferences into regulatory decisions for certain devices, officials explained at a Sept. 18-19 workshop.
CDRH survey to quantify patients’ risk tolerance for obesity device therapies will begin soon, but some physicians and patient advocates are urging caution in applying the data.
Higher-risk devices, based on feasibility trial adverse event rates, would be matched to steeper effectiveness targets in pivotal studies for weight-loss under a plan outlined by the agency.