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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 has approved EnteroMedics Inc.’s Maestro Rechargeable System, a pacemaker-like device used to help obese patients control hunger cravings.

In making the decision the agency took into consideration patients’ willingness to accept higher potential risk of the device which failed to meet its co-primary endpoints in a pivotal study....

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