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FDA Takes Initial Steps To Quantify Patient Opinion

This article was originally published in The Gray Sheet

Executive Summary

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.

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FDA Weighs Patients' Risk Tolerance in Approving Obesity Device

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.

FDA Weighs Patients' Risk Tolerance in Approving Obesity Device

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.

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