Indication for Use: Spiration® Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. Potential Complications: Potential complications which may be associated with bronchoscopy and/or the Spiration® Valve System may include, but are not limited to, pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, and dyspnea and in rare cases, death. Contraindications: Patient is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures; Patients with known or suspected sensitivity or allergy to nickel; Patients with evidence of active pulmonary infection; Patients who have not quit smoking; Patients with large bullae encompassing greater than 30% of either lung; Patients with diffuse homogenous emphysema. Prior to using the Spiration® Valve System, please review the full list of prescriptive information at http://svs.olympusamerica.com/prescriptive-information for additional information on indications, contraindications, warnings, precautions, and potential complications.
