Source: USFDA  Jul 11, 2018  4 years ago
Zephyr Endobronchial Valve approved for severe emphysema, USFDA
Zephyr Endobronchial Valve approved for severe emphysema, USFDA
Source: USFDA  Jul 11, 2018  4 years ago
A new device, the Zephyr Endobronchial Valve (Zephyr Valve), has been approved by the U.S. Food and Drug Administration for the treatment of breathing difficulties associated with severe emphysema.
Zephyr Endobronchial
Valve has been approved after review of data from trial involving 190 patients with emphysema
During a procedure in a hospital setting, the Zephyr Valves are placed into the diseased areas of the lung airways using a flexible bronchoscope. The device is designed to prevent air from entering the damaged parts of the lung and allow the escape of trapped air and fluids.
severe emphysema
Depiction of the Zephyr ® endobronchial valve. Image courtesy of Pulmonx, Inc.
Data were reviewed from a multicenter study of 190 patients with severe emphysema. A total of 128 patients were treated with Zephyr Valves and medical management, including medications and pulmonary rehabilitation, while the control group (62 patients) received medical management alone. At one year, 47.7 percent of patients treated with the Zephyr Valves and 16.8 percent of the control group experienced at least a 15 percent improvement in their pulmonary function scores. Approval for the device was granted to Pulmonx Inc.
"Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines," Tina Kiang, Ph.D., acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices in the FDA's Center for Devices and Radiological Health, said in a statement. "This novel device is a less invasive treatment that expands the options available to patients."

Reference : USFDA


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