According to results from the STELVIO trial, severe emphysema patients chosen via Pulmonx’s Chartis System and treated with Zephyr Endobronchial Valves (EBV) showed durable improvements in lung function, exercise capacity and quality of life at one year.
Of the EBV-treated patients in the STELVIO trial evaluated at one year, 65% showed a clinically meaningful improvement in lung function (FEV1) at 12 months compared with 72% at six months. Similarly, at 12 months, 75% of EBV-treated patients showed a clinically meaningful improvement in distance on the Six Minute Walk Test compared to 77% at six months. The improvement in FEV1 was +17% and in distance on the Six Minute Walk Test was +61 meters. No late pneumothoraces occurred.
“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,” said lead author, Karin Klooster, PhD of the University Medical Center Groningen, The Netherlands.
The one-year analysis of the STELVIO trial included 40 severe emphysema patients previously confirmed with the Chartis System to be likely responders to Zephyr EBV therapy due to the absence of interlobar collateral ventilation, who volunteered to be evaluated at one year. Tiny one-way valves were placed in select airways of patients to block airflow to diseased regions of the lung, with the goal of improving their breathing. The study also included patients that were crossed over from the medical management arm to the EBV treatment arm.
The STELVIO trial is the first randomized, controlled trial of Zephyr EBV therapy using the Chartis System to identify patients most likely to benefit. It is also the first prospective trial to demonstrate that Zephyr EBV therapy can benefit patients regardless of heterogeneous or homogeneous distribution of the disease.
“Zephyr EBV therapy continues to demonstrate its long-term, life-changing benefits when used in combination with the Chartis System for patient selection,” said Pulmonx Chief Executive Officer Glen French. “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.”