Pulmonx Corporation announced today that the French Health Ministry has granted national reimbursement for the Zephyr Endobronchial Valve, the first minimally-invasive treatment option for patients with severe emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD). The Zephyr Valve procedure, done through a simple bronchoscopy with no incision or cutting, is clinically proven to improve patients’ breathing, exercise capacity, and quality of life, without the risks of major surgery.
“This treatment represents a major advancement in interventional pulmonology and will have a significant impact on public health in France. Until now, options were limited for this group of COPD patients, and many struggled to breathe despite maximum medication therapy,” states Dr. Nicolas Guibert, MD, PhD Pulmonology Department, Toulouse University Hospital. “Before Zephyr Valves, patients with advanced disease struggled and were not always good candidates for more invasive surgical procedures. The medical community in France now has a great opportunity to access this option to help patients breathe easier and re-engage with life activities.”
The French Health Technology Assessment (HTA) body – Haute Autorité de Santé (HAS) – issued a positive opinion recognizing the large public health need for the Zephyr Valves across the nation. Assessing the severity of advanced emphysema, limited existing treatments, and the proven clinical benefits of the Zephyr Valve, HAS’s special committee evaluating new technologies recommended the Zephyr Valve be added to the list of reimbursable products. The HAS reimbursement decision validates that treatment with Zephyr Valves, with appropriate patient selection, represents an effective and safe option for emphysema/COPD patients across France.
“This treatment option not only revolutionizes care for emphysema patients but expands the field of interventional pulmonology,” states Prof. Guibert, MD, PhD. “It is an exciting time for lung physicians and a new era for the field.”
“Our goal is to develop technologies that improve the lives of patients with severe pulmonary disease, and we commend the HAS and the French Health Ministry for offering their citizens access to this cutting-edge treatment for emphysema,” states Glen French, CEO of Pulmonx. “By providing reimbursement coverage for the Zephyr Valve, emphysema patients in France will now benefit from improved breathing and quality of life.”
In collaboration with leading medical research centers across Europe, centers in France have been a key part of clinical research, data collection and validation of this innovative technology. The contributions from centers in France have included the validation of the efficacy and safety of treatment with the Zephyr Valve, and the careful selection of eligible patients with the Chartis System, a lung assessment tool developed by Pulmonx. This robust clinical data was the basis for the positive reimbursement decision and shows that the Zephyr Valve is a viable treatment option for severe emphysema that will become a standard procedure under French law. The next crucial step is to ensure patient access to this treatment option. Physicians managing COPD should learn about this treatment option, understand which patients qualify, and refer those patients to a Zephyr trained treatment center.
Source: Company Press Release