Pulmonx Corporation reported positive one-year data from the STELVIO trial, the first randomized study evaluating the Zephyr Endobronchial Valve (EBV) in people with severe emphysema, who were selected using the diagnostic Chartis System to identify those most likely to benefit. The results, presented at the recent 2016 American Thoracic Society (ATS) International Conference, found durable improvements in lung function, exercise capacity, and quality of life in EBV-treated patients.
The one-year analysis of the STELVIO trial included 40 severe emphysema patients confirmed by the Chartis System to be likely responders to Zephyr EBV therapy, due to the absence of interlobar collateral ventilation, who agreed to follow-up. The 68 patients in the six-month trial had been randomized to either EBV treatment or medical management. In those receiving EBV therapy, tiny one-way valves were placed in select airways to block airflow to diseased lung regions, with the goal of improving breathing. (The analysis also included patients crossed over from the management arm to the treatment arm.)
Data showed a 65 percent improvement in lung function at 12 months in these patients, compared with 72 percent at six months. Also at 12 months, 75 percent of the patients demonstrated clinically meaningful improvements in the six minute walk test — with distance improved by 61 meters — compared to 77 percent at six months.
“The endobronchial valve treatment is shown to not only improve lung function, exercise capacity and quality of life across a broad group of emphysema patients, but its benefits are now demonstrated to be sustained over time,” the study’s lead author, Karin Klooster, PhD, with the University Medical Center Groningen, the Netherlands, said in a press release.
“Zephyr EBV therapy continues to demonstrate its long-term, life-changing benefits when used in combination with the Chartis System for patient selection,” said Glen French, chief executive officer of Pulmonx. “The Chartis System’s unique ability to predict patients that will respond to EBV therapy is demonstrated by the positive responder rate, something that no other technology can provide.”
Zephyr EBV blocks airflow to diseased lung regions, allowing healthy regions to expand and function more efficiently. Its use is currently approved in more than 30 countries, not including the United States.