Designed by PulmonX, the valve is about the size of an eraser and can be placed over a flexible bronchoscope at the diseased site in the airways of the lungs. The device then blocks the air from entering the damaged parts of the lungs during inhalation.
More than half of patients with severe emphysema have no collateral ventilation in ≥ 1 lobe target lungs and, as the type of chronic obstructive pulmonary disease (COPD), has been estimated at 3.5 million Americans according to the Centers for Disease Control and Prevention Diagnosed, the approval marks a step towards improving the quality of life of these patients. Over the past decade, PulmonX has implanted more than 40,000 zephyr EBVs in more than 1
"Treatment options are limited for people with emphysema whose symptoms have not improved by taking medications, including lung operations such as lung volume reduction or lung transplantation, which may not be suitable or appropriate for all patients," said Tina Kiang, PhD , Deputy Director of the Department of Anaesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA Center for Equipment and Radiological Health, in a statement. "This novel device is a less invasive treatment that extends the possibilities for patients."
The Authority's decision to approve it was made by reviewing the data from the LIBERATE study, which consisted of 190 enrolled patients in 24 centers for safety and efficacy of the flap with a primary result of forced expiratory volume in 1 second (FEV 1 ) after 1 year. The secondary endpoints included the volume reduction of the treated lung lobe, the 6-minute walking distance (6MWD), and the St. George's Respiratory Questionnaire (SGRQ).
The results showed that 47.7% of patients treated with the Zephyr Endobronchial Valve (n = 128) had an improvement in lung function score of at least 15%, compared with 16.8% of the control group (n = 62). According to the PulmonX statement from 2015, three studies outside the US – BeLieVeR-HIFi, STELVIO and IMPACT – "provide significant evidence that the device is able to significantly improve lung function, exercise tolerance and quality of life in patients without collateral ventilation, evaluated with the Chartis system. "
Adverse events related to the device included death, pneumothorax, pneumonia, worsening emphysema, hemoptysis, shortness of breath, and chest pain. The FDA Contraindications include patients with active lung disease, allergic to nitinol, nickel, titanium or silicone, smokers and those who can not tolerate the bronchoscopic procedure.