Pulmonx has completed patient enrollment in its LIBERATE trial, which will evaluate the safety and efficacy of the Zephyr endobronchial valve (EBV) in people with severe emphysema.
Emphysema is a form of chronic obstructive pulmonary disease (COPD).
Zephyr EBVs are tiny, minimally-invasive and one-way valves, which will be placed in select airways of the lungs to occlude diseased regions and reduce lung hyperinflation.
The randomized and controlled trial will assess the safety and effectiveness of the Zephyr EBV against optimal medical management.
Pulmonx has recruited 190 patients at 24 centers in the multi-center study.
In the trial, the patients with Zephyr EBV will be randomized in 2:1 ratio against control.
According to the company, the primary outcome to be assessed at one year is forced expiratory volume in one second (FEV1, an objective measure of breathing function).
Secondary outcomes that will be evaluated include 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 results from the trial will be used to support approval of the device for use in the US.
Pulmonx CEO Glen French said: “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 US.
“Completing enrollment in this important trial moves us one step closer to making this proven treatment available to US patients who have few options today.”