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Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.
Brief Statement: The Pulmonx Zephyr® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. The Zephyr Valve is contraindicated for: Patients for whom bronchoscopic procedures are contraindicated; those with evidence of active pulmonary infection; known allergies to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium); known allergies to silicone, or with large bullae encompassing greater than 30% of either lung; Patients who have not quit smoking. The Zephyr Valve should be used with caution and only after careful consideration in treating patients with: Prior lung transplant, LVRS, median sternotomy, or lobectomy; Congestive heart failure or recent myocardial infarction; FEV1 <15% of predicted value. Use is restricted to a trained physician. Prior to use, please reference the Zephyr Endobronchial Valve System Instructions for more information on indications, contraindications, warnings, all precautions, and adverse events.
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