Results from the independent, randomized, controlled STELVIO trial in the New England Journal of Medicine demonstrated statistically and clinically significant outcomes in lung function, exercise capacity and quality of life in severe emphysema patients identified with the Pulmonx’s Chartis® patient assessment system, and treated with the Zephyr® Endobronchial Valve (EBV), when compared to those receiving standard medical management.
Background
Well known to readers of our pages for its minimally-invasive treatment for severe emphysema, interventional pulmonology company Pulmonx Corporation, points us at the online publication of results that strongly support its technology: 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. The trial was performed independently of Pulmonx.
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, exercise capacity and quality of life. 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.
The STELVIO trial was led by Karin Klooster and Dirk-Jan Slebos of the Department of Pulmonary Diseases and the Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, The Netherlands. The trial was funded by a Dutch government grant from ZonMW and the University Medical Center Groningen, The Netherlands.
Investigator comments
“When we select patients with the Chartis System, endobronchial valve treatment provides improved lung function, exercise capacity, and quality of life,” said Karin Klooster, lead author of the publication. “When we identify the right patients for treatment, the improvements can be life-changing,“ said Principal Investigator Dr. Dirk-Jan Slebos.
Company comments
“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,” said Pulmonx Chief Executive Officer Glen French.
Source: Pulmonx, Inc.
