Elevair Emphysema Device ‘Not Approvable’: FDA

FDA has issued a “not approvable” letter to PneumRx for its PMA application for Elevair Endobronchial Coil System for treating people with severe emphysema. On 6/14, FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee voted 7 to 5 in favor of the device’s safety, but 8 to 3 that the benefits do not outweigh the risks, and 5 to 7 that the device was effective for use with patients in its proposed indications.  

The nitinol endobronchial coil is intended to be deployed bronchoscopically to reduce lung volume in patients with severe emphysema. The PMA included data from the Renew trial that evaluated the device’s use for over a year. Results from the trial indicated a statistically significant improvement at 12 months in its primary effectiveness endpoint, but there was a “loss of treatment effect beyond 12 month,” according to the agency.