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Pulmonx's FDA Nod: First To US Market With Endobronchial Valve System

 
• By Marion Webb

Pulmonx announced US FDA approval of its Zephyr endobronchial valve system for treating severe emphysema patients. This makes it the first minimally invasive device to be approved in the US for treating severe emphysema, a severe form of chronic obstructive pulmonary disease.

Valves implanted

Almost a decade after FDA first rejected it, the US FDA approved Pulmonx Corp.'s Zephyr valve, making the Redwood City, Calif.-company the first US-based company to gain approval to bring a minimally invasive endobronchial valve for treating severe emphysema patients to the US market.

FDA approved Zephyr based on clinical results from Pulmonx's Liberate study and two other multicenter randomized control trials. Liberate randomized 190 patients with severe heterogeneous emphysema to treatment with...

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