STELVIO Trial Shows Sustained Benefits for Emphysema Patients One Year After Treatment with Zephyr® Endobronchial Valves
Redwood City, Calif. – May 18, 2016 – Pulmonx®, a leader in interventional pulmonology, today announced positive one year results from the groundbreaking STELVIO trial. The STELVIO trial is the first randomized controlled study of Zephyr® Endobronchial Valves (EBV) in severe emphysema patients selected using the Chartis System. EBV-treated patients showed durable improvements in lung function, exercise capacity and quality of life at one year. The results were presented at the American Thoracic Society (ATS) Annual Meeting by the lead author, Karin Klooster, PhD of the University Medical Center Groningen, The Netherlands.
Of the EBV-treated patients in the STELVIO trial evaluated at one year, 65 percent showed a clinically meaningful improvement in lung function (FEV1) at 12 months compared with 72 percent at six months. Similarly, at 12 months, 75 percent of EBV-treated patients showed a clinically meaningful improvement in distance on the Six Minute Walk Test compared to 77 percent at six months. The improvement in FEV1 was +17 percent 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 Dr. Klooster.
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 was led by Dirk-Jan Slebos, MD, PhD, pulmonologist, and Dr. Klooster, study coordinator, 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, and was performed independently of Pulmonx.
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.”
The Zephyr EBV is a minimally-invasive treatment for severe emphysema that has been proven in over a decade of clinical experience to significantly improve the lung function, exercise tolerance and quality of life for patients receiving treatment. The Chartis System is utilized prior to the procedure to identify likely responders. 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 for patients who can then perform more activities of daily life. Zephyr EBVs have been implanted globally in more than 10,000 patients.
Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing life-changing, cost-effective technologies that improve the lives of patients suffering from lung disease worldwide. For more information, visitwww.pulmonx.com
The Zephyr® EBV is an investigational device in the United States. Limited by U.S. law to investigational use.
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