Japan Approves Zephyr Valve for Severe Emphysema
Positive recommendation from PMDA came from two Pulmonx-sponsored clinical trials
Pulmonx has won the green light in Japan to market its Zephyr Endobronchial Valve, a bronchoscope-placed device designed to help people breathe easier who have severe emphysema, a form of chronic obstructive pulmonary disease (COPD).
With the OK from the Japanese Ministry of Health, Labour and Welfare (MHLW), which followed a positive recommendation by the Pharmaceuticals and Medical Devices Agency (PMDA), Japan joins the U.S. among the countries where the device is approved.
The company plans to enter into discussion with the MHLW to gain reimbursement prior to market entry to ensure faster and broader access for patients.
“The Zephyr Valve is a breakthrough technology because it is the first bronchoscopic procedure option that can provide significant improvements to patients with no improvement in their symptoms despite optimal medical therapy,” Masamichi Mineshita, MD, PhD, said in a press release. Mineshita is a professor at St. Marianna University School of Medicine’s Department of Respiratory Medicine, Kawasaki, Japan.
The Zephyr Valve is placed via a bronchoscope, a thin flexible tube inserted through the nose or mouth into the windpipe and air passages that lead to the lungs. Once a valve hits its target position, it blocks off the damaged alveoli — the tiny sacs where gas exchanges take place in the lungs— where air gets trapped.
Trapped air escapes through the valve and relieves pressure on the diaphragm, the thin muscle below the lungs that separates the chest from the abdomen. This allows the healthier parts of the lungs to take in more air and work better.
Multiple valves may be placed to help patients breathe easier, be less short of breath, and have a better quality of life.
“Many patients with advanced disease continue to struggle to breathe, making even simple daily tasks difficult,” Mineshita said. “Having a treatment that can help patients breathe easier and live a better quality of life, without surgical intervention, will be a major step forward in COPD care in Japan.”
The PMDA’s positive recommendation was based on data from two clinical trials sponsored by Pulmonx, LIBERATE (NCT01796392) and IMPACT (NCT02025205).
With more than 280 people with severe emphysema enrolled, both trials showed the Zephyr Valve brought about clinically meaningful improvements in lung function, exercise capacity, and quality of life over time compared with just optimal medical management, which includes medications and treatments such as pulmonary rehabilitation and supplemental oxygen.
“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,” said Glendon French, president and CEO of Pulmonx. “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.”
More than 600,000 Japanese people have severe COPD and about one in six have symptoms despite adhering to their optimal medical management, according to the company.
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