News
FDA panel rejects new airway valve device as a substitute for lung volume-reduction surgery
GAITHERSBURG, MD—An FDA advisory panel recommended today against agency approval of a first-of-its-kind one-way airway valve for emphysema patients, a device billed as a noninvasive substitute for lung volume-reduction surgery.
By an 11-2 vote, the Anesthesiology and Respiratory Therapy Device Panel found insufficient evidence of benefit to outweigh the risks of implanting the Zephyr Endobronchial Valve, manufactured by Emphasys Medical of Redwood City, Calif.
The panel was chaired by anesthesiologist David Birnbach, M.D., M.P.H., of the University of Miami. The affirmative votes were from two pulmonologists, Andrew Reis, M.D., of the University of California San Diego and Philip Marcus, M.D., of the University of Arizona in Tuscan.
Drs. Marcus and Reis argued that the panel should recommend approving the device with some caveats, such as demanding an immediate post-market study, but the panel voted against approving the device with added conditions.
