Pulmonx has secured approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Zephyr Endobronchial Valve for the treatment of patients with severe chronic obstructive pulmonary disease (COPD)/emphysema.
The approval given to the US-based medical technology company follows a positive recommendation by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
According to the firm, the Zephyr Valve is designed to be a minimally invasive treatment that can improve lung function, exercise capacity, as well as the quality of life.
The valves are placed by bronchoscopy, without cutting or incision, in patients who still experience symptoms despite optimal management, including prescription drugs, pulmonary rehabilitation, and supplemental oxygen, said Pulmonx.
During a bronchoscopic surgery, the one-way Zephyr Valves are put in a specific lung lobe to occlude the target lobe and lessen hyperinflation. These release pressure on the diaphragm and enable the healthier sections of the lung to expand and work more efficiently, the company added.
Pulmonx president and CEO Glendon French said: “We are excited about this approval and the opportunity to enable the Japanese medical community to bring a much-needed treatment option to patients with severe COPD/emphysema.
“Japan is the second largest healthcare market in the world and represents a valuable opportunity to bring our innovative treatment to a large group of patients who have had few options once medical management alone fails to control their disease.”
The Japanese approval was based on the PMDA’s review of the positive clinical results of the LIBERATE and IMPACT studies. The LIBERATE study enrolled patients with heterogenous emphysema distribution, while the IMPACT study included patients with homogeneous emphysema distribution.
Both studies demonstrated that Zephyr Valves treatment improved lung function, exercise capacity, and the quality of life in patients more significantly than medical management alone.
