Last month, a Temple University Hospital-led research team reported that implantation of the Zephyr® Endobronchial Valve (Zephyr® EBV®) successfully reduced shortness of breath and improved lung function and quality of life, with benefits lasting at least one-year post-intervention for patients with severe emphysema. The results of that clinical trial, known as LIBERATE, were presented at the ATS International Conference and published simultaneously in the American Journal of Respiratory and Critical Care Medicine. Having completed a review of the study results, the U.S. Food and Drug Administration has granted pre-market approval under its breakthrough devices designation to the Zephyr® EBV® to treat breathing difficulty associated with severe emphysema.
“We’ve been working for decades to identify minimally invasive bronchoscopic treatments for patients with severe emphysema and this is the first device of its kind to receive FDA approval,” said Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and principal investigator of the LIBERATE trial. “FDA approval of this novel device is a major step forward for our ability to offer additional treatment options to these patients.
For patients with severe emphysema, oxygenated air comes in, but not all the air from the last breath is exhaled. Rather, it becomes trapped in the lungs, caught in large pockets formed by the rupture of the lung's tiny air sacs, known as alveoli. Lung volume reduction surgery to remove small portions of damaged lung tissue helps some patients but is invasive and risky. The Zephyr EBV, manufactured by California-based Pulmonx Corporation now provides an alternative for some patients.
The Zephyr valve can be readily placed in an emphysematous lobe of the lung in a procedure called bronchoscopic lung volume reduction (BLVR). Once in place, it functions as a one-way valve, causing the damaged lobe to deflate and preventing further lobar inflation. It thereby reduces hyperinflation, which happens when air becomes trapped in the lungs. Hyperinflation is what makes breathing difficult for emphysema patients.
The Zephyr valve essentially mimics the mechanism of action of lung volume reduction surgery by shrinking the diseased lung region, thereby allowing healthier regions to expand and function with greater efficiency. In the LIBERATE trial, which included 190 patients, almost half of the patients treated with Zephyr® EBV® experienced improved lung function, compared with just 17 percent of patients treated with current standard medical management approaches for emphysema.
Moreover, while the condition of standard-of-care patients did not change or worsen over time, the patients who responded to Zephyr therapy continued to experience clinical benefits 12 months after receiving treatment. Over the long-term, the frequency of adverse events between the two study groups was comparable.
Key to the success of the LIBERATE trial was proper patient selection. In LIBERATE and smaller previous trials, Zephyr was found to be effective in patients who exhibit little to no collateral ventilation, a phenomenon in which air moves around obstructed lung tissues via channels that bypass the normal airways.
The FDA granted pre-market approval to the Zephyr valve under its breakthrough device designation based on the results of LIBERATE.
“Clinical research like LIBERATE drives new programs for clinical care,” added Dr. Criner. “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.”
In addition to leading the LIBERATE trial, the Temple Lung Center has also been selected as a national clinical center of excellence for peer instruction in selection and performance of bronchoscopy lung reduction. Physicians throughout the United States and internationally will come to Temple for instruction on the care and management of endobronchial valve placement.
LIBERATE was funded by Pulmonx Corporation, Redwood City, California.
Editor’s Note: Neither Dr. Criner nor any member of his immediate family has financial interest in Pulmonx.
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