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FDA Panel: Benefits Unproven For BTG Emphysema Treatment

 
• By Elizabeth Orr

An US FDA advisory panel wasn't convinced by data for BTG/PneumRX’s Elevair Endobronchial Coil System during a June 14 meeting. The panel decided that while the emphysema device was reasonably safe, the sponsor hadn’t shown it was effective or that the benefits outweighed the risks.

FDA Advisory Committee Feature image

BTG PLC’s Elevair Endobrochial Coil System failed in its bid for an approval recommendation from US FDA’s Anesthesiology and Respiratory Devices Panel during a June 14 meeting. Panelists said the sponsor’s data didn’t show clearly enough whether patients would see more benefit than risk from the first-of-its-kind device.

The panel voted 7-5 that the device is safe, but 5-7 against effectiveness. And only three panelists voted that the device's benefits outweighed its risks, with eight voting against that...

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