Pulmonx Files PMA for Emphysema Device

Pulmonx Corp. has filed a PMA for the Zephyr Endobronchial Valve (EBV), a removable device designed to treat severe emphysema. The company says Zephyr 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 submission is based on data from the LIBERATE Study, a landmark randomized controlled trial that enrolled 190 patients with severe emphysema at 24 centers in the U.S. and Europe. The trial endpoints at one year included measures of lung function, exercise tolerance and quality of life. It also included data from the TRANSFORM, IMPACT and STELVIO studies.

“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,” Pulmonx says. “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.”