Pulmonx, Inc. Gets FDA Nod for U.S. Trial of Emphysema Therapy
8/28/2012 10:03:02 AM
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Pulmonx, an emerging leader in interventional pulmonology, announced today that the U.S. Food and Drug Administration (FDA) has approved its request for an Investigational Device Exemption (IDE) to commence a multi-center pivotal clinical trial. Pulmonx intends to use the results from this trial to support a subsequent premarket approval application (PMA) for the Zephyr® Endobronchial Valve (EBV). This new trial will incorporate the use of the Pulmonx Chartis System to plan valve treatment.