The Food and Drug Administration (FDA) has approved the Zephyr Endobronchial Valve (Pulmonx Inc) to treat patients with severe emphysema.
The Zephyr Valve is placed during a bronchoscopic procedure into the diseased areas of the lungs in order to prevent air from entering the damaged parts. The valves close during inhalation, preventing air from entering the damaged part of the lung, and open during exhalation, letting out trapped air and relieving pressure.
“Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines,” said Tina Kiang, PhD, of the FDA’s Center for Devices and Radiological Health. “This novel device is a less invasive treatment that expands the options available to patients.”
The approval was based on results from a multicenter study (LIBERATE) of 190 patients with severe emphysema. Participants were treated with either Zephyr Valves and medical management including medications (N=128) or medical management only (control group; N=62). At 1 year, 47.7% of the Zephyr Valve group experienced ≥15% improvement in their pulmonary function scores vs 16.8% of the control group.
The Zephyr Valve device is contraindicated in patients with active lung infections, those who are allergic to nitinol, nickel, titanium or silicone, active smokers, and those who cannot tolerate bronchoscopic procedures. To help identify potential patients for treatment, clinicians can use the Pulmonx Chartis Pulmonary Assessment System and StratX Lung Analysis Platform.
For more information visit Pulmonx.com.