Pulmonx® is touting another piece of data, supportive of its Zephyr® Endobronchial Valve (EBV). Results from a retrospective analysis of the landmark VENT trial, presented at this year’s American Thoracic Society (ATS) Annual Meeting, demonstrated a statistically significant benefit in severe emphysema patients with homogeneous disease, treated with the system.
The retrospective analysis of the VENT trial examined outcomes of Zephyr EBV treatment in 25 patients with homogeneous disease distribution yielded statistically significant 16% improvement in FEV1 compared to the baseline. The conclusion is that patients with homogeneous disease who have low collateral ventilation can benefit from endobronchial lung volume reduction. The findings were presented by Professor Felix Herth, MD, PhD, FCCP, Chairman and Head of Pneumology and Respiratory Care at Thoraxklinik, University of Heidelberg.
As a result of the promising results seen in the VENT analysis, Pulmonx also announced active enrollment in the prospective, randomized, multi-center IMPACT study, the first study to examine the benefits of the Zephyr EBV exclusively in a homogeneous patient population. The study will enroll 56 patients to assess the clinical efficacy of the Zephyr EBV versus medical management. The IMPACT study leverages improved techniques not utilized in VENT for patient screening, selection and treatment, including using HRCT analysis and functional assessments of collateral ventilation using the Chartis system.
“While the VENT trial was not originally designed to evaluate patients with homogeneous disease, in our retrospective review we found that a number of them were included. Upon close examination of this group, we found that the Zephyr valves showed significant promise in improving their symptoms, which warranted further study,” said Professor Herth.
“We are actively researching ways to bring the benefits of our therapies to a broader range of patients,” said Pulmonx Chief Executive Officer Glen French. “In addition to identifying homogeneous patients that may be treated with our Zephyr valve, and enrolling our U.S. LIBERATE study, we are enhancing our recently acquired AeriSeal therapy to allow patients with collateral ventilation to be eligible for treatment.”
Source: Pulmonx, Inc.