The valve is the first minimally invasive device approved in the United States for treating such patients, according to Pulmonx, the device manufacturer.
The FDA previously granted the novel device expedited review, as patients who did not respond to drug treatment had only limited alternative options, including lung volume reduction and lung transplant, Tina Kiang, PhD, of the FDA’s Center for Devices and Radiological Health, said in a press release. “This novel device is a less invasive treatment that expands the options available to patients,” said Dr. Kiang, acting director of the center’s Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices.
The approval is based on a multicenter study of 190 patients with severe emphysema. A total of 128 received Zephyr valves and medical management, while 62 received medical management only. The primary measure was the number of patients who achieved at least a 15% improvement in their pulmonary function score: At 1 year, 47.7% of the Zephyr valve patients had achieved such improvement versus 16.8% of the control group, according to the FDA.
Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath, and chest pain. The valve is contraindicated in patients with active lung infections; those allergic to nitinol, nickel, titanium, or silicone; and active smokers.
Read more about this approval in the full FDA press announcement.