Pulmonx Closing in On Approval for Valve to Treat Emphysema

Pulmonx has some additional ammunition in its bid to get its severe emphysema treatment valve FDA approval. The Redwood City, CA-based company released positive one-year-results from the LIBERATE pivotal trial of the Zephyr Endobronchial Valve, which shows the study met all primary and secondary endpoints in treating emphysema patients. Emphysema falls under the umbrella of chronic obstructive pulmonary disease (COPD) and is characterized by damage to the walls of the lungs between the air sacs, according to the National Emphysema Foundation. This damage causes the sacs to lose their shape and often, the destruction of those walls, leading to fewer and larger air sacs instead of many tiny ones. As a result, the amount of gas exchanged in the lungs is reduced and patients have difficulty breathing. “We put in our filing with FDA at the very end of last year,” Beran Rose, VP of Marketing and Business Development, Pulmonx, told MD+DI. “The [filing] was a particularly strong package because it included not only the data from our U.S. pivotal study, but also the data from four prior studies done with this device. We’re really excited about the prospect of commercializing this technology in the U.S. should FDA approve it, and we’re hoping that may be sometime in the second half of this year.” LIBERATE evaluated the effectiveness and safety of the Zephyr Endobronchial Valve out to one year in patients with severe heterogeneous emphysema with little to no collateral vent...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news