Results from the 6-month, independent, randomized, controlled STELVIO trial validated the safety and efficacy of the Pulmonx Zephyr Endobronchial Valve (EBV) in severe emphysema patients, according to data presented at the American Thoracic Society Annual Meeting and reported by Pulmonx.

Pulmonx-Zephyr-Valve-closeupThe Zephyr EBV is a minimally invasive treatment for severe emphysema that has been proven to significantly improve the lung function, exercise tolerance and quality of life for patients receiving treatment, according to Pulmonx.

In the procedure, tiny, one-way valves are placed in the lungs to block airflow to diseased regions to achieve lung volume reduction. As a result, the remaining healthy regions may function more efficiently, enabling better breathing and an improved quality of life, Pulmonx explains.

The STELVIO trial compared the Zephyr EBV with standard medical care in 84 severe emphysema patients. Using the Chartis system, 68 patients were confirmed to have no collateral ventilation, independent of disease distribution, and were treated with the Zephyr EBV.

At six months, statistically and clinically significant improvements in pulmonary function, exercise capacity and quality of life were seen in this patient cohort, as described in the following chart:

Measurement (MCID) Improvement from Control Responder Rate
FEV1% (15%) 23% 63%
6MWT (26 m) 106 meters 87%
SGRQ (-4 points) -15 points 79%

“The benefit of the Zephyr EBV is undeniable in emphysema patients without collateral ventilation,” said primary investigator Dr Dirk-Jan Slebos of the Department of Pulmonary Diseases and the Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, The Netherlands. “What is clear is that we, as physicians, must both carefully select the patients for this treatment and technically perform a successful procedure. When we do, the improvements can be life-changing for a patient group that up until now has had very limited treatment options.”

The trial has been funded by a Dutch government grant from ZonMW and the University Medical Center Groningen, The Netherlands.

The Zephyr EBV is an investigational device in the United States.

Pulmonx reports that 3 additional randomized controlled trials — VENTEuroVENT and BeLieVeR-HIFi — have demonstrated benefits of the Zephyr EBV in severe emphysema patients with heterogeneous disease, and a US pivotal trial – the LIBERATE study – is currently enrolling.