Pulmonx said today data from the Stelvio trial of its Chartis system and Zephyr endobronchial valve demonstrated statistically and clinically significant outcomes in lung function, exercise capacity and quality of life in severe emphysema patients.
Data from the study was published today in the New England Journal of Medicine.
“When we select patients with the Chartis System, endobronchial valve treatment provides improved lung function, exercise capacity, and quality of life. When we identify the right patients for treatment, the improvements can be life-changing,” publication lead author Karin Klooster said in prepared remarks.
Pulmonx said the randomized, controlled Stelvio trial was its 1st to examine the use of its Zephyr EBV therapy in combination with the use of its Chartis system to identify patients likely to benefit.
In the trial, 68 patients were cleared through the Chartis system as receptive candidates for the Zephyr EBV therapy, and were randomized to either receive the EBV therapy or medical management.
At 6-months, patients in the EBV group reported statistically greater improvements in pulmonary function at 20.9% vs 3.1% in the control group. EBV patients also displayed increased exercise capacity and quality of life scores, and more patients in the group were reported to have responded to the treatment.
Patients in the control group who had EBV therapy after 6 months showed similar benefits to the originally treated EBV group, the company said.
“The Stelvio study provides independent confirmation that a broad range of patients with advanced emphysema have a high likelihood of achieving clinically meaningful benefits from Zephyr EBV therapy when a systematic approach is followed and careful patient selection is performed using the Chartis System,” CEO Glen French said in a press release.
The Zephyr EBV valves are placed in a minimally invasive treatment into the lung ot block airflow to diseased regions of the lung to achieve lung volume reductions.
In July, Pulmonx said a sham-controlled trial of its Zephyr endobronchial valve met and exceeded its primary endpoints, reporting a 20.9% average improvement in lung function.
The Believer-Hifi study, published in The Lancet, is the 1st successful sham-controlled trial of any invasive emphysema device, Redwood City, Calif.-based Pulmonx said.