Pulmonx recently announced positive results from the IMPACT (NCT02025205) study assessing the company’s proprietary Zephyr endobronchial valve (EBV), showing that patients with homogeneous emphysema benefit from the treatment.
The Zephyr EBV is a small one-way valve placed in the lungs to block airflow to diseased regions to reduce lung volume.
The results from the IMPACT study were published in the American Journal of Respiratory and Critical Care Medicine under the title “Endobronchial Valve Therapy in Patients with Homogeneous Emphysema: Results from the IMPACT Study.”
The IMPACT study enrolled 93 patients to compare the safety and effectiveness of Zephyr EBV against standard medical care after the patients were pre-selected with the Chartis system, a Pulmonx diagnostic tool that identifies which patients are eligible to receive the Zephyr valve procedure. In this case, the system selected patients with little to no collateral ventilation, the population who would most likely benefit from EBV treatment.
“Endobronchial valve treatment has previously shown definitive benefits in patients with heterogeneous disease; we wanted to see if patients with homogeneous emphysema could also benefit from this proven, minimally-invasive approach for lung volume reduction,” Dr. Ralf Eberhardt, MD, professor at the Thoraxklinik at the University of Heidelberg and co-principal investigator of the IMPACT study, said in a press release.
“In the IMPACT study, we found that EBV treatment resulted in statistically and clinically significant improvements versus controls in pulmonary function, exercise capacity and quality of life in patients with severe homogenous emphysema and negative collateral ventilation,” Eberhardt said.
Eberhardt presented the results of the study earlier this month at the 26th International Congress of the European Respiratory Society (ERS).
IMPACT was the first prospective, randomized, multi-center study to examine the effectiveness of the investigational Zephyr EBV specifically in patients with homogenous emphysema.
Three-month results demonstrated that patients treated with EBV experienced meaningful improvements in lung function, with a 17 percent improvement in forced expiratory volume in one second (FEV1), in exercise tolerance with a 40-meter increase in the six-minute walk test (6MWD), and in quality of life, with a 10-point improvement in the St. Georges Respiratory Questionnaire (SGRQ) score. All results reported are in comparison with the study’s control group.
The results showed that 97 percent of the subjects treated with Zephyr EBV experienced target lobe volume reduction, indicating effective occlusion of the target lobe following EBV placement. These data suggest that EBV therapy could bring substantial benefits to more patients than previously thought.
“The IMPACT results show that selecting the right patient for endobronchial valve treatment is now simpler. We should focus on patients with hyperinflation and the absence of collateral ventilation, rather than on the homogeneity or heterogeneity of the disease,” said Dr. Arschang Valipour, MD, FCCP, associate professor of the Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology at Otto-Wagner-Spital in Vienna, Austria, the paper’s lead author and co-principal investigator of the IMPACT study.
The authors also noted that despite the limited options available to treat these patients, they believe EBV treatment should be considered as an effective alternative.
“These results prove that a substantially broader range of patients can benefit from the Zephyr Endobronchial Valve than previously estimated,” said Pulmonx CEO Glen French. “As the most proven minimally invasive lung volume reduction procedure for severe emphysema, the Zephyr EBV now offers hope to a new group of patients who currently have very few therapeutic options.”
Watch a video of the Zephyr EBV procedure below: