Lung treatment company Pulmonx won FDA approval to begin pivotal clinical trials of its Zephyr Endobronchial Valve in treating patients with emphysema.
The minimally invasive Zephyr device is a one-way bronchial valve designed to reduce volume in diseased areas of the lungs, allowing healthier areas to work better. It’s implanted bronchoscopically and can be removed later if necessary, according to a press release.
Pulmonx already has CE Mark approval to market the device in the European Union, where it has been used to treat about 4,000 patients so far. More than 40% of those treatments occurred in the last year, the company reported.
"Emphysema is a terribly debilitating disease that affects the lives of literally millions of Americans," Zephyr study co-lead investigator Dr. Armin Ernst said in prepared remarks. "There is a large, unmet need for non-invasive treatment of emphysema designed for patients who currently have very few options in the U.S."
Pulmonx hopes to use results from the pivotal trial to support a pre-market approval bid with the FDA, according to the press release.
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