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# FDA Approves Pulmonx Zephyr Endobronchial Valve
- URL: https://www.fdaweb.com/fda-approves-pulmonx-zephyr-endobronchial-valve/
- Published: 2018-06-29T12:00:00.000Z
- Updated: 2026-09-15T00:17:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141803

FDA has approved a Pulmonx PMA for the Zephyr Endobronchial Valve, intended to treat breathing difficulty associated with severe emphysema. “Using a flexible bronchoscope, a doctor places Zephyr Valves, similar in size to pencil erasers, into the diseased areas of the lung airways during a procedure in a hospital setting,” an [FDA release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612271.htm?utm%5Fcampaign=06292018%5FPR%5FFDA%20approves%20device%20for%20treating%20breathing%20difficulty%20from%20emphysema&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. The device is designed to prevent air from entering the damaged parts of the lung and allow trapped air and fluids to escape. During inhalation, the valves close and during exhalation, the valves open, letting out trapped air, which is intended to relieve pressure, the agency says.

  
Approval was based on data from a multi-center study of 190 patients with severe emphysema. At one year, 47.7% of patients treated with Zephyr Valves experienced at least a 15% improvement in their pulmonary function scores, compared with 16.8% of patients in the control group, FDA says. Adverse events observed in the study included death, air leak (pneumothorax), pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain, it says.