Results from the STELVIO trial involving a combination of Zephyr EBV therapy with the Chartis System diagnostic tool revealed significant improvements for patients with severe emphysema. The results were published in the New England Journal of Medicine on Dec. 9, 2015, in a study titled, “Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation.”
Emphysema, a form of chronic obstructive pulmonary disease (COPD), is characterized by the blockage of airflow in the lungs that makes it difficult to breathe. COPD has no known cure, but can be managed by various therapies to limit its progression. Among these, Zephyr EBV is a low-invasive treatment for severe emphysema used for over a decade and shown to substantially improve the lung function, exercise tolerance, and quality of life in patients without interlobar collateral ventilation. The Chartis System is a pulmonary diagnostic tool.
In the STELVIO trial, led by Karin Klooster and Dirk-Jan Slebos at UMCG in The Netherlands, a total of 68 patients were confirmed by Chartis System to respond well to Zephyr EBV therapy, and were then randomized to receive either medical management or EBV therapy. For those under EBV therapy, tiny one-way valves were inserted into their lungs to improve breathing by preventing airflow to unhealthy regions.
The results suggest that a large number of patients in the EBV group responded well to the treatment. At six months, the EBV group showed significant statistical and clinical improvements in terms of pulmonary function, exercise capacity as measured by the 6 Minute Walk Test, and overall quality of life compared to the medical management group. Additionally, when control patients also received EBV therapy at the end of six months, they showed comparable benefits.
“When we identify the right patients for treatment, the improvements can be life-changing,” said the principal investigator, Dr. Dirk-Jan Slebos.
Overall, the combination of Zephyr EBV therapy in emphysema patients identified by the Chartis System appears to be a promising treatment approach.
“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 Glen French, Pulmonx’s chief executive officer.