Pulmonology treatments company Pulmonx Corp reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) for the first minimally-invasive device Zephyr Endobronchial Valve System for treating severe emphysema patients, a progressive and life-threatening form of chronic obstructive pulmonary disease (COPD).
The company added that the Pulmonx Zephyr Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. During a bronchoscopic procedure, 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.
This US FDA approval is based on positive clinical data from the company's pivotal LIBERATE Study as well as two other multicenter randomised control trials.
Under the company's 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.
In conjunction, the Zephyr Valve treatment is included in emphysema treatment guidance issued by leading health organisations worldwide, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the UK's National Institute for Health and Care Excellence (NICE), concluded the company.
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