Severe Emphysema Treatment Device Approved by FDA

Published Online: Friday, June 29th, 2018
A new device intended to treat breathing difficulty associated with severe emphysema was approved today by the FDA. The device, Pulmonx’s Zephyr Endobronchial Valve (Zephyr Valve) is a less invasive treatment than options currently available to patients.

“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, PhD, acting director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA’s Center for Devices and Radiological Health, in a statement.

Using a flexible bronchoscope about the size of a pencil eraser, a doctor places Zephyr Valves into the diseased areas of the lung airways during a procedure in a hospital setting. The device’s design is intended to prevent air from entering the damaged parts of the lung, while also allowing trapped air and fluids to escape.

The FDA reviewed data from a multicenter study of 190 patients with severe emphysema. In this study, 128 patients were treated with Zephyr Valves and medical management, according to current clinical guidelines, including medications, and pulmonary rehabilitation. Sixty-two patients (the control group) received medical management only. Results of treatment were measured by how many patients in each arm of the study had at least a 15% improvement in pulmonary function scores. At one year, 47.7% of patients treated with Zephyr Valves experienced at least a 15% improvement in their pulmonary function scores, compared with 16.8% of patients in the control group.

Adverse effects observed in the study include death, air leak, 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 speak with healthcare providers to determine if the Zephyr Valve device is appropriate for them.

The Zephyr Valve was granted Breakthrough Device designation. It was reviewed by the FDA through the premarket approval review pathway, a regulatory pathway for the highest risk class of devices.


Reference

FDA approves novel device for treating breathing difficulty from severe emphysema [news release]. Silver Spring, MD: June 29, 2018; FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612271.htm. Accessed June 29, 2018.
 


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