Important Safety Information

Zephyr ^® valve

Zephyr Endobronchial Valve Summary: The Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve designed to control airflow to improve lung function and/or reduce fistulas in patients with hyperinflation associated with severe emphysema with little or no collateral ventilation. The Zephyr Valve is contraindicated in: Patients in whom bronchoscopic procedures are contraindicated; Patients with evidence of active pulmonary infection; Patients with known allergies to nitinol (nickel-titanium) or its metal components (nickel or titanium); Patients with known allergies to silicone; Active smokers. Use is reserved for trained physicians. Before use, all additional information on indications, contraindications, warnings, precautions and adverse reactions in the Zephyr Endobronchial Valve System Instructions for Use should be consulted.

This information material is not intended for use in France, Denmark, Switzerland, Belgium, Cyprus, Greece, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Slovakia and Spain.

The Chartis ^® System

Brief summary of the Chartis System: The Chartis System is indicated for use by the performing physician during diagnostic bronchoscopy in adult patients with chronic obstructive pulmonary disease (COPD) and emphysema in a bronchoscopy unit. The system consists of the Chartis catheter and the Chartis console and is designed to measure pressure and flow to calculate airflow resistance and quantify collateral ventilation in isolated lung compartments. The Chartis catheter is inserted through the working channel of a bronchoscope and is connected to the Chartis console. The Chartis console is a reusable device for displaying patient data. The Chartis System is contraindicated in the presence of active infection or severe hemorrhagic diathesis. No interfering substances are known. Use is reserved for trained physicians. Before use, please refer to the Chartis System Instructions for Use/User Manual for additional information on indications, contraindications, warnings, precautions and adverse reactions.

EUR-DE-1657-v1