Pulmonx® Corp. has filed a Premarket Approval (PMA) application with the U.S. FDA for the Zephyr® Endobronchial Valve (EBV®), a minimally-invasive and removable device designed to treat severe emphysema.
Background
COPD is the third leading cause of death in the U.S., behind heart disease and cancer. Because it is often underdiagnosed, it is estimated that between 12 million and 24 million Americans have COPD, costing the U.S. almost $50 billion in direct and indirect costs. Almost five million Americans have a severe form of COPD known as emphysema.
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.
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.
Pulmonx Zephyr EBV is already available in Europe and clinicians have implanted more than 50,000 globally in more than 12,000 patients. The U.S. PMA was based on the successful execution of Pulmonx’s pivotal IDE trial, 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.
Three previous randomized controlled trials of the Zephyr EBV provide a robust body of evidence showing 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.
Company comments
“We are proud to be leading the industry in developing rigorous and robust clinical evidence for this technology, which is consistently demonstrating the value of Zephyr EBVs in improving the lives of emphysema patients,” said Pulmonx CEO Glen French. “Assuming a positive reception from the FDA, we look forward to bringing the Zephyr EBV to U.S. pulmonologists and their emphysema patients who are desperately seeking new treatments.”
Source: Pulmonx, Inc.
published: January 15, 2018 in: Clinical Studies/Trials, Regulatory, Thoracic/Respiratory