Pulmonx®, a leader in interventional pulmonology, tells us that 10,000 patients have been treated to-date with its Zephyr® Endobronchial Valve (EBV).
The Zephyr® EBV is a minimally invasive treatment for severe emphysema that has been proven over a decade of clinical experience to significantly improve the lung function, exercise tolerance and quality of life for patients receiving treatment.
Approved for commercial use in 41 countries, and with more than 200 hospitals currently using it, more than 25,000 Zephyr EBVs have been implanted globally since 2005. The system remains an investigational device in the United States, limited by U.S. law to investigational use.
In the implantation 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.
Prior to the Zephyr EBV procedure, a proprietary diagnostic test called the Chartis System is utilized to identify likely responders to the therapy with a high degree of certainty.
Three randomized controlled trials – VENT, EuroVENT and BeLieVeR-HIFi – have demonstrated the significant benefits of the Zephyr EBV in severe emphysema patients with low collateral ventilation, and a U.S. pivotal trial – the LIBERATE Study – is currently enrolling. Based on promising results in homogeneous patients in prior studies, the company is also undertaking the IMPACT randomized trial to evaluate the benefits of EBV therapy in patients with homogeneous disease and low collateral ventilation.
“The Zephyr device has been shown to be simple, safe and effective in providing sustained improvement in patients’ ability to breathe, their quality of life and exercise capacity,” said Professor Felix Herth, MD, PhD, FCCP, Chairman and Head of Pneumology and Respiratory Care at Thoraxklinik, University of Heidelberg. “Using the Zephyr EBV with the Chartis diagnostic uniquely enables physicians to accurately predict those patients that will benefit from the therapy. The fact that it is removable also provides us as physicians with flexibility in treatment options.”
“Treating 10,000 patients represents a major milestone for Pulmonx as it illustrates our technology’s growing popularity among interventional pulmonologists and thoracic surgeons globally and our commitment to continuous clinical validation,” said Pulmonx Chief Executive Officer Glen French. “It is gratifying to be able to improve the lives of so many people, and we look forward to expanding our patient base to benefit those suffering from severe homogeneous emphysema.”
Source: PulmonX, Inc.