The Zephyr Endobronchial Valve has been given market approval by the Food and Drug Administration.
The treatment is for those with severe emphysema, which is a type of chronic obstructive pulmonary disease.
The treatment works by a physician placing a Zephyr Valve in the diseased areas of the lung airways. The device is meant to prevent air from entering the damaged parts of the lung and allow trapped air and fluids to escape. When a person inhales, the valves close, preventing air for hitting the damaged part of the lung. When he or she exhales, the valves open, letting out trapped air. This can relieve pressure on the lungs.
“Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients,” said Tina Kiang, Ph.D., acting director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA’s Center for Devices and Radiological Health. “This novel device is a less invasive treatment that expands the options available to patients.”
In a multicenter study, almost half of those with the Zephyr Valves had a 15% improvement in their pulmonary function scores.
The FDA reviewed the Zephyr Valve device through the premarket approval review pathway.
