This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Zephyr® Endobronchial Valve System
PMA Applicant: Pulmonx Corporation
Address: 700 Chesapeake Drive, Redwood City, CA 94063
Approval Date: June 29, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180002a.pdf
What is it? The Zephyr Endobrochial Valve System is an implantable bronchial valve used to reduce over inflation of the lungs due to severe emphysema in adults. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane.
How does it work? Using a flexible bronchoscope, a doctor implants the Zephyr Endobrochial Valve into the airways leading to diseased areas of the lung to allow healthy parts of the lungs to expand and thereby decrease shortness of breath. During inhalation, the valves close, stopping air from entering the damaged part of the lung. During exhalation, the valves open letting out trapped air, which is intended to reduce pressure. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
When is it used? The Zephyr Endobrochial Valve is indicated for the treatment of adult patients whose lungs are overinflated by trapped air due to severe emphysema.
What will it accomplish? In a multi-center study of 190 patients with severe emphysema, 128 patients were implanted with Zephyr valves and 62 patients (the control group) received medical management only. Results of the study showed that the patients implanted with Zephyr Endobrochial Valves experienced improvement in pulmonary function scores (the volume of air that can forcibly be blown out in one second after full inhalation).
When should it not be used? The Zephyr Endobrochial Valves should not be used in patients who:
- cannot have a bronchoscopic procedure.
- have active lung infection.
- have an allergy to the device materials (nitinol, nickel, titanium, or silicone).
- are active smokers.
- have an air pocket that is greater than 1/3 of the size of the lung.
Additional information (including warnings, precautions, and adverse events):