Temple Study Leads to First FDA-approved Endobronchial Valve Treatment for Emphysema

The Zephyr® endobronchial valve, FDA-approved after a Temple-led study, allows for deflation of emphysematous air pockets without surgery.

Following a Temple-led study, this summer the FDA approved the first minimally invasive bronchoscopic treatment for patients with advanced emphysema and severe hyperinflation who remain symptomatic despite maximal medical therapy. The LIBERATE trial of the Pulmonx Zephyr® endobronchial valve, led by Lung Center Director Gerard J. Criner, MD, FACP, FACCP, found significant benefits over current standard-of-care medical therapy for patients with severe heterogeneous or homogeneous emphysema and hyperinflation. Improvements in lung function, dyspnea, exercise capacity, and quality of life are now verified as lasting at least 12 months post-procedure.

Previously, patients with severe emphysema had few options for symptom reduction and quality-of-life improvement. Lung volume reduction surgery (LVRS) can help, but is not appropriate for all patients. Less-invasive endobronchial valves, like the Zephyr® Valve, allow for deflation of emphysematous air pockets without surgery, by allowing air to flow out of the damaged parts of the lung and not get back in. This shrinks the treated lung region so healthier regions can expand and function with greater efficiency.

The LIBERATE trial looked at the effects of valve placement over the course of a full year, with 190 patients in 25 centers in four countries. Almost half (47.7%) of patients treated with Zephyr® Valve experienced improved lung function (improvement in FEV1 of ≥15%), compared with 16.8 percent of patients treated with standard medical management approaches for emphysema. Patients receiving the endobronchial valve experienced higher levels of adverse events initially (mainly pneumothorax), but their improvements in symptoms reversed that trend over time, such that the long-term frequency of adverse events between the two study groups was comparable.

Dr. Criner presented the results of the LIBERATE study May 22 at the American Thoracic Society 2018 International Conference, and they were simultaneously published in the American Journal of Respiratory and Critical Care Medicine1. In June, the FDA gave the Zephyr® Valve premarket approval and it is now commercially available, including at the Temple Lung Center.

To inquire about current and future clinical trials, please contact us at 215-707-1359, or to refer a patient, 215-707-5555.


References

1 Criner, G.J., et al. 2018. A Multicenter RCT of Zephyr® Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. May 22 (online). doi: 10.1164/rccm.201803-0590OC