The FDA has approved Pulmonx’s Zephyr Endobronchial Valve for use in the treatment of severe emphysema. Pulmonx secured premarket approval on the strength of clinical data linking the valve to improved pulmonary function.
Zephyr is a pencil eraser-sized device that is delivered to the lung in a minimally invasive procedure. Once in place, the device stops air from entering diseased parts of the lung during inhalation while allowing air and fluids out during exhalation. This mechanism is designed to counter the tendency for air to become trapped by damaged alveoli and, in turn, stop the buildup of pressure and breathing difficulties that characterize severe emphysema.
Pulmonx tested the idea in a 190-patient clinical trial. Two-thirds of the participants received Zephyr plus standard medical management, such as drugs and pulmonary rehabilitation. The other subjects only received standard medical management.
After one year, 48% of patients in the Zephyr group had experienced a 15% or greater improvement in pulmonary function. Around 17% of patients in the control arm experienced such an improvement, suggesting Zephyr boosted lung capacity. The FDA found the data compelling enough to approve the valve.
The regulatory clearance gives physicians and the patients they treat an alternative to surgical procedures such as lung volume reduction and lung transplants. Like Zephyr, these procedures seek to address the buildup of air in diseased lungs but they require unhealthy people to undergo major surgery. Given that, Pulmonx’s valve may be preferable to some severe emphysema patients.
“Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines,” the FDA’s Tina Kiang, Ph.D., said in a statement. “This novel device is a less invasive treatment that expands the options available to patients.”