Emphasys’ Endobronchial Valve For Emphysema Is “Not Approvable” – Panel
This article was originally published in The Gray Sheet
Executive Summary
Emphasys Medical's Zephyr endobronchial valve shows promise as a treatment for severe heterogeneous emphysema but lacks sufficient efficacy data to merit FDA approval, the agency's Anesthesiology and Respiratory Therapy Devices panel determined in an 11-2 vote Dec. 5