Zephyr endobronchial valves already reimbursed in Europe -VIDEO
French Health Ministry has granted in May 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, announced manufacturer Pulmonx.
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.
FDA approved it in 2018
In June 2018, the FDA approved Zephyr endobronchial valves, manufactured by Pulmonx, as the first bronchoscopic treatment for emphysema in the United States for patients with hyperinflation and minimal collateral ventilation. The role of these endobronchial valves in the management of emphysema was evaluated in the LIBERATE study published in American Journal of Respiratory and Critical Care Medicine in 2018.
Results of the trial showed a 15 percent improvement in pulmonary capacity among 48 percent of those patients treated with the valve, compared with an improvement of 15 percent in only 17 percent of the control group. Stanford was one of the clinical trial sites.
New report confirms Zephyr Valve effectiveness
A new publication this month in the Annals of the American Thoracic Society confirms the effectiveness of the Zephyr Valve® in improving dyspnea, ability to exercise, and quality of life for patients with COPD/emphysema. The Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels and Quality of Life at One Year is an in-depth analysis of multiple patient-reported measures captured in the pivotal multicenter LIBERATE Study with the longest follow-up (out to 12-months). This post-hoc analysis demonstrated statistically significant and clinically meaningful improvements in multiple patient-reported measures of breathlessness, activity, and psychosocial status favoring the Zephyr Valve over Control at 12-months, Pulmonx announced.
Key findings include:
- Patients with severe emphysema and hyperinflation treated with Zephyr Valve experience “moderate” to “large” improvements in multidimensional scores for breathlessness, activity and psychosocial parameters.
- Patients treated with the Zephyr Valves experienced significantly more days when their symptoms were “better” and fewer days that were “worse” over 12 months compared to the control group.
- 55% of Zephyr Valve-treated patients achieved a clinically meaningful change in TDI focal score which indicates a return to work/leisure activities previously limited by their breathlessness.
- By improving patients’ breathlessness, the Zephyr Valves broke the cycle of limited exercise and social activity brought on by the disease. Breaking this cycle is important as reduced physical activity is a predictor of future risk of exacerbation, hospitalization, and early mortality.
Concept behind the Zephyr valve
What we’ve learned is that air can get trapped in the damaged portion of the lung for years and years,” explains US pulmonologist Chirag Pandya, MDat Stanford Health Care – ValleyCare. “The lung balloons full of air and you can’t breathe it out. If you could find a way to prevent air from going in, while allowing it to come out, that pressure could be relieved.”
That’s the concept behind the Zephyr valve. Using a flexible bronchoscope, a doctor usually places several one-way valves in the diseased portion of the airways. When the patient breathes in, the valves close, preventing air from entering. During exhalation, the airways open again, releasing the trapped air.
Listen more in the VIDEO below: