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FDA approves Zephyr Valve for severe emphysema
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The FDA today approved the Zephyr endobronchial valve for treating breathing difficulty associated with severe emphysema, according to a press release.
“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, 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 the release. “This novel device is a less invasive treatment that expands the options available to patients.”
The small device is placed into the diseased areas of the lung airways with a flexible bronchoscope, according to the FDA. The Zephyr valve (Pulmonx) prevents air from entering the damaged parts of the lung and allows trapped air and fluids to escape, according to the FDA.
The FDA approval is based on results from a study involving 190 patients with severe emphysema.
Participants were divided into an intervention group and control group. Those in the intervention group received treatment with Zephyr valves, pulmonary rehabilitation and medical management with medications such as bronchodilators, corticosteroids, antibiotics or anti-inflammatory maintenance drugs that were in alignment with current clinical guidelines (n = 128). Those in the control group only received medical management (n = 62).
The study revealed that at 1 year, pulmonary function scores were improved by at least 15% in nearly half of participants (47.7%) treated with Zephyr valves vs. 16.8% of patients in the control group.
Adverse events including death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain were observed, according to the FDA.
The FDA noted that the Zephyr valve is contraindicated for patients with active lung infections, active smokers, those unable to tolerate the bronchoscopic procedure and those allergic to nitinol, nickel, titanium or silicone.
Patients who have had major lung procedures, heart disease, large bubbles of air trapped in the lung or who have not responded to other treatments should talk with their providers to determine whether the Zephyr valve device is appropriate for them.
“Zephyr valves are a major step forward in treating severe emphysema patients who consistently feel short of breath despite all the medications we can offer,” Gerard Criner, MD, chair and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, said in a separate press release issued by Pulmonx. “I have seen Zephyr valve-treated patients getting back to a more active life doing the things they enjoy. As a physician, it is very gratifying to have a new treatment that can restore a patient’s confidence and change their life for the long term.”
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