FDA OKs Zephyr Endobronchial Valve for Breathing Difficulties in Emphysema

The US Food and Drug Administration (FDA) has announced the approval of a new device intended to treat breathing difficulties associated with severe emphysema, the Zephyr Endobronchial Valve.

Developed by PulmonX, the valve is about the size of a pencil’s eraser and can be placed in the diseased locale in the lung airways via a flexible bronchoscope. The device then blocks off air from entering the damaged parts of the lung during inhalation.

More than half of severe emphysema patients have no collateral ventilation in ≥1 target lobes of the lung, and as the type of chronic obstructive pulmonary disease (COPD), has been diagnosed in an estimated 3.5 million Americans according to the Centers for Disease Control and Prevention, the approval marks a step in improving these patients’ quality of life. Over the past decade, according to PulmonX, more than 40,000 Zephyr EBVs have been implanted globally in more than 12,000 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, the 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, in a statement. “This novel device is a less invasive treatment that expands the options available to patients.”

The agency’s decision for approval was made through the reviewal of data from the LIBERATE study, which consisted of 190 enrolled patients at 24 centers to evaluate the safety and effectiveness of the valve with a primary outcome of Forced Expiratory Volume in 1 second (FEV₁) to be evaluated at 1 year. The secondary outcomes included the volume reduction of the treated lobe of the lung, the Six Minute Walk Distance (6MWD) and the St. George’s Respiratory Questionnaire (SGRQ).

Results revealed that 47.7% of those treated with the Zephyr Endobronchial Valve (n = 128) experienced at least a ≥15% improvement on pulmonary function scores, compared with 16.8% of the control group (n = 62). Additionally, according to PulmonX statement in 2015, a trio of studies conducted outside of the US—BeLieVeR-HIFi, STELVIO and IMPACT—"provide a significant body of evidence supporting the device’s ability to significantly improve lung function, exercise tolerance and quality of life in patients with no collateral ventilation, as assessed with the Chartis System.”

Adverse events related to the device included death, pneumothorax, pneumonia, the worsening of emphysema, coughing up blood, shortness of breath, and chest pain. The FDA has noted its contraindications include patients with active lung infections; those who are allergic to nitinol, nickel, titanium or silicone; smokers; and those who are not able to tolerate the bronchoscopic procedure.