FDA Approves Zephyr Valve for Patients with Severe Emphysema

The U.S. Food and Drug Administration (FDA) has approved Pulmonx’s Zephyr Endobronchial Valve, a device designed to treat patients with severe emphysema who experience difficulty breathing.

Emphysema is a type of chronic obstructive pulmonary disease (COPD) that results from damage to the alveoli, the small air sacs in the lung. Damaged alveoli cause air to become trapped in the lungs, ultimately depriving the body from the oxygen it requires. It is estimated that 3.5 million American adults are diagnosed with emphysema.

Currently, there are very few treatment options for patients with severe emphysema.

“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,” Tina Kiang, PhD, said in a press release. Kiang is acting director in the division of anesthesiology 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,” Kiang added.

Zephyr valves are small, minimally-invasive valves that are placed in damaged lung airways. Once in place, these valves block damaged regions, allowing healthy lung regions to work more efficiently. During inhalation, Zephyr valves close, which prevents air from entering the damaged part of the lung. During exhalation, the valves open, which helps let out the trapped air, which relieves pressure.

The Zephyr valves are inserted in the patient’s airway through the use of a flexible bronchoscope operated by a doctor in a hospital setting.

The use of Zephyr valves has been linked with improved breathing and improved quality of life for patients.

Prior to approving Zephyr valves, the FDA reviewed clinical data from a multi-center study assessing 190 patients with severe emphysema (NCT01796392).

In total, 128 of 190 patients were treated with Zephyr valves in addition to optimal medical management as designated by current clinical guidelines, which include medications such as bronchodilators, corticosteroids, antibiotics, or anti-inflammatory maintenance medications, as well as pulmonary rehabilitation (a program of exercise, education, and support to help improve lung function).

The remaining 62 patients (the control group) received medical management only.

Results indicated that one year after treatment, almost half (47.7%) of the patients treated with Zephyr valves experienced a 15% (or more) improvement in lung function scores, compared to only 16.8% of patients in the control group.

Taken together, the results suggest that Zephyr valves can offer a significant clinical benefit to patients with severe emphysema.

Of note, the Zephyr valve is not indicated for patients with active lung infections, including those who are allergic to nitinol, nickel, titanium or silicone, active smokers, and those who can’t undergo the bronchoscopic procedure.