“This treatment represents a major advance in interventional pneumology and will have a significant impact on public health in France. Until now, options were limited for this group of COPD patients, and many have had difficulty breathing despite maximum drug therapy, “said Dr. Nicolas Guibert, MD, PhD Department of Pulmonology, Toulouse University Hospital. “Before Zephyr valves, patients with advanced disease had difficulty and were not always good candidates for more invasive surgery. The medical community in France now has a great opportunity to access this option to help patients breathe easier and resume their life activities. “
The French health technology assessment body (HTA) – Haute Autorité de Santé (HAS) – has issued a positive opinion recognizing the great public health need for Zephyr valves across the country. To assess the severity of advanced emphysema, limited existing treatments, and proven clinical benefits of the Zephyr valve, the HAS Special Committee for the Evaluation of New Technologies recommended that the Zephyr valve be added to the list of refundable products. The HAS reimbursement decision validates that treatment with Zephyr valves, with appropriate patient selection, represents an effective and safe option for patients with emphysema / COPD throughout France.
“This treatment option not only revolutionizes the care of emphysema patients, but expands the field of interventional pulmonology,” said Professor Guibert, MD, PhD. “This is an exciting time for pulmonary physicians and a new era for the field.”
“Our goal is to develop technologies that improve the lives of patients with severe lung disease, and we congratulate HAS and the French Ministry of Health for offering their citizens access to this advanced treatment for emphysema, ”said Glen French, CEO of Pulmonx. “By offering reimbursement coverage for the Zephyr valve, patients with emphysema in France will now benefit from improved breathing and improved quality of life.”
In collaboration with the main medical research centers across Europe, the centers in France have been a key element in clinical research, data collection and validation of this innovative technology. Contributions from centers in France included validation of the efficacy and safety of treatment with the Zephyr valve and rigorous selection of eligible patients with the Chartis system, a pulmonary assessment tool developed by Pulmonx. These solid clinical data were the basis for the positive reimbursement decision and show that the Zephyr valve is a viable treatment option for severe emphysema which will become standard procedure under French law. The next critical step is to ensure that patients have access to this treatment option. Doctors managing COPD should learn about this treatment option, understand which patients are eligible, and refer these patients to a treatment center trained by Zephyr. For more information on patient selection and treatment centers, visit www.Pulmonx.com.
About bronchoscopic reduction of lung volume with the Zephyr valve
Bronchoscopic reduction of lung volume with the Zephyr valve is a unique procedure performed using a bronchoscope, which requires no cutting or incision. During the procedure, an average of four valves are placed in the airways to block a diseased part of the lung, which is thus reduced in size. Reducing hyperinflation and preventing air from getting trapped in diseased areas of the lung allows healthier lung tissue to expand and take in more air. As a result, patients can breathe easier and experience less shortness of breath. Many patients treated with Zephyr valves have reported immediate relief and the ability to resume daily tasks more easily in the weeks following treatment.
In its latest update, the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), led by experts around the world, has improved its evidence rating for the use of valves in the treatment of emphysema as as level A proof, the highest possible rating. The GOLD and the National Institute for Health and Care Excellence (NICE) in the United Kingdom recommend that patients with severe emphysema and hyperinflation be referred for evaluation and consideration for appropriate treatment, which may include valves or lung volume reduction surgery.
About emphysema, a form of COPD
More than 65 million people suffer from COPD worldwide, and an estimated 3.2 million deaths were caused by the disease in 2015 (5% of all deaths worldwide). Emphysema is a debilitating and potentially fatal form of COPD and accounts for approximately 25% of all COPD patients. Emphysema gradually destroys lung tissue, resulting in a decrease in the ability to breathe and engage in the most basic daily activities, leading to further deconditioning and a high mortality rate. Medical therapy offers limited benefits in advanced patients, and due to the high risks and limited availability, surgical options are only available for a narrow patient population. It is estimated that more than 1.2 million patients with severe emphysema in the United States, Europe and Japan are candidates for treatment of the Zephyr valve.
Pulmonx Corporation is a commercial medical device company that provides minimally invasive treatment for patients with severe emphysema, a form of COPD. The Pulmonx solution, which includes the Zephyr endobronchial valve (Zephyr valve), the Chartis pulmonary assessment system (Chartis system) and the StratX pulmonary analysis platform, is designed to treat patients with severe emphysema who, despite medical care, are always deeply symptomatic. and either do not want or are not eligible for surgical approaches. The FDA has granted the Zephyr valve a designation of “revolutionary device” and, in June 2018, Pulmonx received prior approval from the FDA for the commercialization of our Zephyr valve. The Zephyr valve is now commercially available in more than 25 countries, with more than 76,000 valves used to treat more than 19,000 patients. For more information, visit www.MyLungsMyLife.com.
1 Am J Respir Crit Care Med. 2018; 198 (9): 1151-1164.