REDWOOD CITY, Calif.--(BUSINESS WIRE)--Pulmonx®, a leader in interventional pulmonology, today announced publication in The Lancet of results from the BeLieVeR-HIFi clinical trial, the first successful sham-controlled trial of any minimally invasive emphysema device.
BeLieVeR-HIFi is a prospective, double-blind, randomized, sham-controlled trial comparing use of Pulmonx’s minimally invasive valve treatment for severe emphysema patients – the Zephyr® Endobronchial Valve – to a sham bronchoscopy procedure. The study exceeded its primary endpoint, demonstrating a 20.9 percent average improvement in lung function (FEV1) in treated patients compared to control patients. Clinical and statistical significance on several secondary endpoints was also demonstrated, including exercise capacity and gas trapping. There was no statistical difference between groups in safety.
“We have been able to show, for the first time in a rigorous randomized controlled trial, that endobronchial valves can improve lung function and exercise capacity and achieve similar results to those seen with lung volume reduction surgery in properly selected patients,” said Dr. Nick Hopkinson, chief investigator of the study, in an announcement from the National Institute for Health Research.
“In the study, we also saw that likely responders identified with the Chartis system experienced better outcomes than those selected with CT visual assessment alone,” he said.
Pulmonx Chief Executive Officer Glen French said, “An ever-growing body of evidence supports the benefits of the Zephyr EBV in improving breathing and quality of life for patients. These data also demonstrate the benefit of the combined use of the Chartis system and Zephyr valves.”
Zephyr EBVs are tiny, one-way valves placed in the lungs to block airflow to diseased regions in order to achieve lung volume reduction. Following treatment, the remaining healthy regions are intended to function more efficiently, enabling better breathing and improved quality of life. Zephyr EBVs have been implanted globally in more than 10,000 patients. The Chartis system is utilized immediately prior to the valve procedure to identify those patients that are most likely to respond to endobronchial valve treatment.
Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing life-changing, cost-effective technologies that improve the lives of patients suffering from lung disease worldwide. For more information, visit www.pulmonx.com.
The Zephyr® EBV is an investigational device in the United States. Limited by U.S. law to investigational use.