11 January 2018 - - Redwood City, California- and Neuchâtel, Switzerland-based interventional pulmonology company Pulmonx Corp. has filed a premarket approval application with the US Food and Drug Administration for the Zephyr Endobronchial Valve (EBV), a minimally-invasive and removable device designed to treat severe emphysema, the company said.
The Zephyr EBV is the only device designed for emphysema that has a clinically-validated diagnostic tool, the Chartis System, which can identify likely responders in order to optimize patient outcomes.
The filing was based on Pulmonx's pivotal IDE trial, the LIBERATE Study, a randomized controlled trial that enrolled 190 patients with severe emphysema at 24 centers in the US and Europe. The trial endpoints at one year included measures of lung function, exercise tolerance, and quality of life.
Three previous randomized controlled trials of the Zephyr EBV (TRANSFORM, IMPACT and STELVIO) also show that the treatment improves breathing, exercise capacity, and quality of life, while demonstrating long-term safety, in emphysema patients with little or no collateral ventilation as assessed with the Chartis System.
Zephyr EBVs are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways in the lungs to block diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions of the lung can function more efficiently, enabling better breathing and an improved quality of life for patients.
Zephyr EBVs are widely used Europe, Australia, Asia, and South America as a treatment for severe emphysema. Over the past 10 years, more than 50,000 Zephyr EBVs have been implanted globally in more than 12,000 patients.
Pulmonx is focused on developing life-changing, cost-effective technologies that improve the lives of patients suffering from lung disease worldwide.