FDA Approves the Pulmonx Zephyr Valve for Emphysema Patients
In late June, the FDA approved the Zephyr Endobronchial Valve System, which is the first minimally-invasive device approved in the United States for treating patients with severe emphysema, a progressive and life-threatening form of chronic obstructive pulmonary disease (COPD).
The valve was granted an expedited review as the FDA stated in the Summary of Safety and Effectiveness Data that the Zephyr Valve “represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated risks. This device offers significant clinically meaningful advantage over the current standard of care and therefore its availability is also in the best interest of patients."
The approval is based on positive clinical data from the pivotal LIBERATE Study and two other multicenter randomized control trials. In the LIBERATE study, patients treated with Zephyr Valves were able to breathe easier, be more active and energetic, be less short of breath, and enjoy a significantly improved quality of life compared to patients who received medical management alone.
“Zephyr Valves are a major step forward in treating severe emphysema patients who consistently feel short of breath despite all the medications we can offer. I have seen Zephyr Valve-treated patients getting back to a more active life doing the things they enjoy. As a physician, it is very gratifying to have a new treatment that can restore a patient’s confidence and change their life for the long term,” said Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, and lead investigator for the LIBERATE Study.
What is the Pulmonx Zephyr Valve?
During a bronchoscopic procedure requiring no cutting or incisions, tiny Zephyr Valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation. This helps the healthier parts of the lungs to expand and lifts pressure off the diaphragm, thereby decreasing shortness of breath and making breathing easier.
“It is gratifying to be able to tell the many US patients who have contacted us that help is on the way. We thank FDA for its swift review of the Zephyr Valve. By combining the Zephyr Valves and our patient selection tools, we are bringing precision medicine to the treatment of severe emphysema,” said Pulmonx CEO Glen French.