FDA clears novel device for severe emphysema

July 2, 2018

FDA approved a novel device to treat breathing difficulty associated with severe emphysema.

FDA approved a novel device to treat breathing difficulty associated with severe emphysema.

The Zephyr Endobronchial Valve (Pulmonx), which was granted breakthrough device designation by FDA, is inserted into the diseased areas of the lung airways during a procedure in a hospital setting.

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.

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“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 FDA’s Center for Devices and Radiological Health, in a statement from the agency. “This novel device is a less invasive treatment that expands the options available to patients.”

The Centers for Disease Control and Prevention estimates that 3.5 million American adults have been diagnosed with emphysema.

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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 (bronchodilators, corticosteroids, antibiotics or anti-inflammatory maintenance medications) and pulmonary rehabilitation, while 62 patients (the control group) received medical management only.

At 1 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 events observed in the study include death, air leak (pneumothorax), pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain.

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