The US Food and Drug Administration (FDA) has given pulmonary medical device manufacturers Pulmonx permission to initiate an investigational device exemption (IDE) pivotal clinical study for its Zephyr endobronchial valve therapy, designed to treat emphysema.
The multi-centre trial is designed to study the safety and efficacy of Zephyr in reducing volume in the diseased portion of the lungs, thereby improving the ability of the healthier portions of the lungs to function.
The trial will incorporate the use of the Pulmonx Chartis system to plan valve treatment, according to the company.
A recent multi-centre 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 Dr Gerard J Criner said a recently published trial in Europe highlighted the benefits of Chartis technology in planning endobronchial valve treatments.
"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 said.
The company intends to use the IDE study data to support a premarket approval application (PMA) to the FDA for the approval of Zephyr.
Image: Pulmonx has gained FDA IDE approval to study the Zephyr Endobronchial Valve therapy. Photo: Courtesy of FDA.