The
Zephyr Endobronchial Valve is an endobronchial implant designed to occlude a
hyperinflated lobe of the lungs with multiple valves, allowing air to escape while
blocking airflow into the treated lobe. This is intended to result in a reduction
in lung volume and hyperinflation in the targeted area. This one-way valve
therapy leads to an improvement of lung function, exercise tolerance, and
quality of life in patients with advanced emphysema.
Key inclusion criteria:
- Severe emphysema: forced expiratory volume in 1 second (FEV1) ≤ 45% of predicted, TLC ≥ 100% of predicted, RV ≥ 150% of predicted
- Resting partial pressure of arterial carbon dioxide (Paco2) ≤ 60 mm Hg
- Resting partial pressure of arterial oxygen (Pao2) on room air ≥ 45 mm Hg
- Body mass index ≤ 31 kg/m2 for men, ≤ 32 kg/m2 for women
- Abstinence from smoking for at least six months
- Completion of pulmonary rehabilitation.