The US Food and Drug Administration (FDA) has granted approval to Pulmonx to commence an investigational device exemption (IDE) pivotal clinical study of its Zephyr Endobronchial Valve (EBV) therapy, designed to treat emphysema.
The multi-center trial is designed to study the safety and efficacy of Zephyr EBV therapy in reducing volume in the diseased portion of the lungs, thereby improving the ability of the healthier portions of the lungs to function.
In addition, the trial will incorporate the use of the Pulmonx Chartis system to plan valve treatment.
Recent multi-center European study of Zephyr, using Chartis, demonstrated a statistically significant improvement in target lobe volume reduction and FEV1 at 30 days compared to those who were predicted not to respond.
The patients also showed a mean percentage increase in FEV1 of 16% and a mean improvement in quality of life as scored by the St. George’s Respiratory Questionnaire (SGRQ), a clinically validated quality of life measure.
Temple University School of Medicine pulmonary and critical care medicine chief and Zephyr trial co-principal investigator Gerard J. Criner said a recently published trial in Europe has also shown that it is possible to use the new Chartis technology to obtain with better consistency greater clinical responses in lung function, exercise tolerance, and quality of life measures than was seen in the overall results from the earlier VENT study.
"If we can confirm these benefits in this pivotal trial, Pulmonx’s Zephyr EBV therapy could represent an important breakthrough in the treatment of emphysema in the US," Criner added.
The company intends to use the IDE study data to support a premarket approval application (PMA) to the FDA for the approval of Zephyr EBV therapy.