Spiration Valve System 9 mm European Post Market Evaluation Study

• Patient is older than 40 years in age
• Patient has severe heterogeneous emphysema with moderate to severe dyspnea as defined as an mMRC of 2 or greater.
• The target lobe and ipsilateral lobe will be separated with an intact fissure, as determined by HRCT (> 90% integrity).
• Patient has received standard-of-care medical management and it has been stable for 6 weeks.
• Patient can walk a minimum of 140 meters in the six minute walk test.
• Patient's obstructive disease is severe as defined by: FEV1 ≤45% of predicted
• Patient's hyperinflation is defined by: RV ≥ 150% of predicted
• Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period

Exclusion Criteria:

• Patient does not have at least one airway with the intention to be treated with a 9 mm Spiration Valve based on a calibrated balloon sizing of the airway.
• Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study
• Patient is unable to provide informed consent
• Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures
• Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the 3 months prior to baseline testing.
• Patient has giant bulla (> 1/3 volume of lung)
• Patient has severe pulmonary hypertension.
• Patient has bronchiectasis
• Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
• Patient has had prior lung volume reduction surgery, intra-bronchial valve therapy for emphysema, or major lung procedures (lobectomy or greater).
• Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
• Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study