Trial results for Zephyr EBV therapy in severe emphysema published in New England Journal of Medicine- Pulmonx

Pulmonx has announced online publication of results from the independent, randomized, controlled STELVIO trial in the New England Journal of Medicine. The trial demonstrated statistically and clinically significant outcomes in lung function, exercise capacity and quality of life in severe emphysema patients identified with the Chartis System, Pulmonx’s proprietary assessment system, and treated with the Zephyr Endobronchial Valve (EBV), when compared to those receiving standard medical management. 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 a broad range of advanced stage emphysema patients, including those with heterogeneous disease, where emphysema is isolated to specific areas of the lungs, and homogeneous disease, where emphysema is distributed evenly throughout the lungs.

In the STELVIO trial, 68 patients were confirmed with the Chartis System to be likely responders to Zephyr EBV therapy, and randomized to either EBV therapy or medical management. In patients who received EBV therapy, tiny one-way valves were placed in the lungs to block airflow to diseased regions with the goal of improving breathing. At six months, compared to the medical management group, the EBV group had statistically and clinically greater improvements in pulmonary function (FEV1 change % predicted, EBV vs Control: 20.9% vs 3.1%), exercise capacity (6 Minute Walk Test, EBV vs Control: +19.6% vs -3.6%) and quality of life (SGRQ score, EBV vs Control: -21.8 vs -7.6). Also, a significantly greater number of patients in the EBV group responded to treatment. At the end of six months, control patients that crossed over to receive EBV therapy gained benefits similar to the original EBV-treated group.