Interventional pulmonology specialist, Pulmonx® has announced completion of enrollment in its pivotal IDE study. Results will support approval of the device for use in the U.S.
A frequent visitor to our pages, Pulmonx Zephyr Endobronchial Valve (EBV) are tiny, minimally-invasive, one-way valves placed in select airways of the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions may function more efficiently, enabling better breathing and an improved quality of life for patients.
The LIBERATE Trial is a randomized, controlled, multi-center study of the Zephyr EBV in patients with severe emphysema. It enrolled 190 patients at 24 centers to evaluate the safety and effectiveness of the Zephyr EBV versus optimal medical management, with patients randomized 2:1 Zephyr EBV versus control. The primary outcome to be evaluated at one year is Forced Expiratory Volume in one second (FEV1, an objective measure of breathing function). Secondary outcomes are volume reduction of the treated lobe of the lung, the Six Minute Walk Distance (6MWD, a measure of exercise tolerance) and the St. George’s Respiratory Questionnaire (SGRQ, a measure of quality of life).
“The Zephyr EBV is the most studied endoscopic lung volume reduction device globally and is considered first-line therapy by leading physicians outside of the U.S.,” said Pulmonx Chief Executive Officer Glen French. “Completing enrollment in this important trial moves us one step closer to making this proven treatment available to U.S. patients who have few options today.”
Source: Pulmonx, Inc.