On June 29, 2018, the FDA granted Pulmonx Inc. approval to market a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated 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,” said 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. “This novel device is a less invasive treatment that expands the options available to patients.”
The CDC estimates that 3.5 million American adults have been diagnosed with emphysema. Emphysema, including severe emphysema, is a type of chronic obstructive pulmonary disease (COPD) due to damage to the air sacs (alveoli) in the lungs. Lung damage from emphysema is irreversible. The damaged alveoli can cause used air to become trapped in the lungs during exhalation. This can cause the diseased parts of the lung to get larger and put pressure on the healthy part of the lung, which makes it difficult to breathe. As a result, the body may not get the oxygen it needs.
Using a flexible bronchoscope, a doctor places Zephyr Valves, similar in size to pencil erasers, into the diseased areas of the lung airways during a procedure in a hospital setting. The device is designed to prevent air from entering the damaged parts of the lung and allow trapped air and fluids to escape. During inhalation, the valves close, preventing air from entering the damaged part of the lung. During exhalation, the valves open, letting out trapped air to relieve pressure.
The FDA reviewed data from a study of patients with severe emphysema. In this study, some patients were treated with Zephyr Valves and medical management according to current clinical guidelines, including medications (bronchodilators, corticosteroids, antibiotics, or anti-inflammatory maintenance medications) and pulmonary rehabilitation, while other patients (the control group) received medical management only. After one year, 47.7 percent of patients treated with Zephyr Valves experienced at least a 15 percent improvement in their pulmonary function scores (the volume of air that can forcibly be blown out in one second after full inhalation), compared with 16.8 percent of patients in the control group. Adverse events observed in the study included death, air leak (pneumothorax), pneumonia, worsening of emphysema, coughing up blood, shortness of breath, and chest pain.
The Zephyr Valve device is contraindicated for patients with active lung infections; those who are allergic to nitinol, nickel, titanium, or silicone; active smokers; and those who are not able to tolerate the bronchoscopic procedure. 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 if the Zephyr Valve device is appropriate for them.
See the FDA Announcement
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