Important Safety Information
Indication: 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.
Contraindication: 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.
Warnings: 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.
Adverse Effects: Probable adverse events include, but are not limited to, the following: Acute respiratory distress syndrome; Airway erosion; Airway stenosis; Aphonia; Bowel function impairment; Bronchitis; Bronchospasm; Chest Pain; COPD exacerbation; Cough; Death; Disorientation/anxiety; Dyspnea; Empyema; Epistaxis; Fever; Granulation tissue/ulceration formation; Headache; Heart arrhythmia; Heart Failure; Hematoma; Hemoptysis; Hemothorax; Hypotension; Hypercapnia; Hypoxemia; Iatrogenic injuries; Impaired lung function; Increased mucus secretions; Infection; Insomnia; Musculoskeletal event; Myocardial infarction; Nausea/vomiting; Pain; Pleural effusion; Pneumonia; Pneumothorax; Pulmonary embolism; Pulmonary shunting; Residual volume increase; Respiratory failure; Sepsis; Shortness of breath; Sore throat; Stroke/CVA/TIA; Systemic inflammatory response syndrome (SIRS); Valve migration/expectoration; Vocal cord injury; Wheeze or whistling.
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.