The regulatory approval follows the receipt of a positive recommendation by the Pharmaceuticals and Medical Devices Agency (PMDA).
The Zephyr Valve is said to be a minimally invasive treatment option that can improve lung function, exercise capacity and quality of life.
The valves are placed through bronchoscopy, without cutting or incision, for patients who still have symptoms despite optimal management, which includes supplemental oxygen, pulmonary rehabilitation and medications.
During the bronchoscopic surgery, the one-way Zephyr Valves are put in a specific lung lobe (often in the most diseased lobe) to occlude the target lobe and minimise hyperinflation.
Pulmonx stated that this releases some of the pressure on the diaphragm and enables the healthy lung tissue to expand and work more efficiently.
This helps patients breathe more easily and reduces shortness of breath, leading to improved quality of life.
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 regulatory approval was based on the PMDA’s review of the positive clinical data obtained from the LIBERATE and IMPACT studies.
The IMPACT Study enrolled patients with homogeneous emphysema distribution and the pivotal LIBERATE Study included patients with heterogenous emphysema distribution.
Both studies demonstrated that treatment with Zephyr Valves improved lung function, exercise capacity and quality of life in patients more significantly compared to medical treatments alone.
The company plans to work with the Japanese MHLW to get reimbursement before the Zephyr Valve is launched in the country to ensure wider access to its clinically proven treatment.