The Food and Drug Administration has approved the Zephyr Endobronchial Valve (Zephyr Valve), a device to treat breathing difficulty associated with severe emphysema.

The device operates in a straightforward manner: 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. Clinicians use a flexible bronchoscope, a device designed to prevent air from entering the damaged parts of the lung, while allowing trapped air and fluids to escape. During inhalation, the valves close, and prevent air from entering the damaged part of the lung; during exhalation, the valves open–letting out trapped air, which is intended to relieve pressure.

“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,” says 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 FDA cited statistics issued by the Centers for Disease Control and Prevention, which estimate that 3.5 million American adults have been diagnosed with emphysema. Emphysema is a type of chronic obstructive pulmonary disease (COPD) that occurs due to damage in 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 ultimately enlarge the diseased parts of the lung, and put pressure on the healthy part of the lung–which makes it difficult to breathe. As a result, the body may not receive necessary oxygen.

Data from a multi-center study of 190 patients with severe emphysema was reviewed by the FDA. In the study, 128 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. Some 62 patients (the control group) solely received medical management.

According to the FDA, at one year, 47.7 percent of patients treated with Zephyr Valves experienced at least a 15 percent improvement in their pulmonary function scores, 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 was granted ‘Breakthrough Device’ designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, intended to expedite evidence generation and the agency’s review of the device. According to an FDA spokesperson, “To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.” The FDA granted approval of the Zephyr Valve device to Pulmonx Inc.

SOURCE
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612271.htm