FDA approves novel device for treating breathing difficulty from severe emphysema

FDA has approved a new device (Zephyr Endobronchial Valve—Pulmonx Inc.) for the treatment of breathing difficulty associated with severe emphysema.

FDA has approved a new device (Zephyr Endobronchial Valve—Pulmonx Inc.) for the treatment of breathing difficulty associated with severe emphysema. Noting the limited treatment options for individuals with severe emphysema who have tried taking medications, Tina King, PhD, acting director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in Fads Center for Devices and Radiological Health, said: "This novel device is a less invasive treatment that expands the options available to patients." FDA explained that a doctor using a flexible bronchoscope places the Zephyr valves into the diseased areas of the lung airways during a hospital procedure. The device is designed to keep air from entering the diseased parts of the lung while enabling trapped air and fluids to escape. The valves close during inhalation, preventing air from entering the damaged part of the lung, and then during exhalation, the valves open, so trapped air can escape and relieve pressure. The new device is contraindicated for individuals with active lung infections; those who are allergic to nitinol, nickel, titanium or silicone; active smokers; and those who are not able to tolerate the bronchoscopic procedure.