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US FDA Encourages Close Look At Safety Of Emphysema Device

 
• By Elizabeth Orr

The safety risks of an implanted device used to treat hyperinflated lungs associated with severe emphysema will be discussed at a June 14 FDA panel meeting on a PMA submission for the device from BTG.

Close-up of a doctor against a blue background next to a silhouette of lungs.

A device up for discussion before US FDA's Anesthesiology and Respiratory Therapy Devices Panel on June 14 could improve quality of life for patients with severe emphysema. But adverse-event reports from clinical trials of the Elevair Endobronchial Coil System from BTG PLC/PneumRx Inc. have the agency urging panelists to closely review safety considerations, according to an FDA executive summary released in advance of the meeting.

Patients with emphysema often experience lung hyperinflation, which means exhalation becomes more difficult as air gets trapped in the lungs....

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