The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The […]
Pulmonx touts quality of life, lung function improvements in 1-year Zephyr endobronchial valve IDE study
Pulmonx yesterday released one-year results from the pivotal trial of its Zephyr endobronchial valve designed to treat patients with severe emphysema from chronic obstructive pulmonary disease, touting significant improvements in lung function and quality of life. Results from the study were presented at the American Thoracic Society 2018 international conference and published in the American Journal […]
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British health agency backs endobronchial valves from Pulmonx, OIympus
Pulmonx and Olympus (TYO:7733) won a nod from a British health agency for the endobronchial valves they sell to treat severe emphysema. The U.K.’s National Institute for Health & Care Excellence updated its guidance for the valves, saying it considers the clinical evidence behind them sufficient to support routine use. The one-way valves, Pulmonx’s Zephyr and the Spiration […]
Pulmonx touts Chartis, Zephyr combo-treatment study
Pulmonx said today data from the Stelvio trial of its Chartis system and Zephyr endobronchial valve demonstrated statistically and clinically significant outcomes in lung function, exercise capacity and quality of life in severe emphysema patients. Data from the study was published today in the New England Journal of Medicine. “When we select patients with the […]
Pulmonx touts sham trial data
Pulmonx said earlier this month that a sham-controlled trial of its Zephyr endobronchial valve met and exceeded its primary endpoints, reporting a 20.9% average improvement in lung function. The Believer-Hifi study, published in The Lancet, is the 1st successful sham-controlled trial of any invasive emphysema device, Redwood City, Calif.-based Pulmonx said. “We have been able […]
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Pulmonx wins FDA nod to launch pivotal trials for emphysema treatment
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.
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