A new device called Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema bagged US FDA Approval. The device, Pulmonx’s Zephyr Endobronchial Valve (Zephyr Valve) is a less invasive treatment than options currently available to patients.
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. The FDA granted approval of the Zephyr Valve device to Pulmonx Inc.
Zephyr Valves, similar in size to pencil erasers is placed by a doctor using a flexible bronchoscope, into the diseased areas of the lung airways. The Design of the device is intended 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 and during exhalation, the valves open, letting out trapped air, which is intended to relieve pressure.
The FDA reviewed data from a multi-center study of 190 patients with severe emphysema, out of which 128 patients were treated with Zephyr including medications (bronchodilators, corticosteroids, antibiotics or anti-inflammatory maintenance medications) and pulmonary rehabilitation, while 62 patients (the control group) received medical management only. The primary outcome was at least a 15 percent improvement in pulmonary function scores (the volume of air that can forcibly be blown out in one second after full inhalation).
Adverse events observed in the study include death, air leak (pneumothorax), pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain.
The Zephyr Valve has been granted Breakthrough Device designation under which FDA has provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. 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 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.
Emphysema is a type of chronic obstructive pulmonary disease (COPD) caused due to damage to the air sacs (alveoli) in the lungs which 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 is deprived of the required oxygen that it needs.