Pulmonx secure Japanese approval for Zephyr Valve for COPD/emphysema
pharmafile | December 1, 2022 | News story | Medical Communications |
Pulmonx, a US-based medical technology company, has secured approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for its Zephyr Endobronchial Valve, used to treat patients with severe chronic obstructive pulmonary disease (COPD) or emphysema.
The approval follows a positive recommendation from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), which was given after the review of clinical results from the LIBERATE ‒ patients with heterogenous emphysema distribution ‒ and IMPACT ‒patients with homogenous emphysema distribution ‒ studies. Both demonstrated that Zephyr Valves improved lung function, exercise capacity and the quality of life for patients.
Designed to be minimally invasive, the one-way Zephyr Valves are put into a lung lobe during a bronchoscopic surgery (without incision) to occlude the unhealthy lobe and lessen hyperinflation. This releases pressure on the diaphragm, which enables healthier sections on the lung to expand and work more efficiently.
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.”