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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