FDA Rejects Endobronchial Coil System for Treating Severe Emphysema

Elevair’s premarket approval (PMA) application for its endobronchial coil device was shot down by the FDA.

The coil system is meant to reduce lung volume and hyperinflation by applying compression to damaged tissue and helping the lungs regain elastic recoil.

The device is designed to treat severe emphysema using a minimally invasive, bronchoscopic technique to place memory coils in the patient’s lungs.