The Spiration Valve System for the Treatment of Severe Emphysema

Inclusion criteria

• Patient has severe emphysema and high heterogeneity by visual assessment defined as:

• a target lobe with ≥ 40% emphysema involvement and
• ≥ 15% difference with the ipsilateral lobe.
• The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be ≥90% complete after viewing the HRCT in 3 dimensions.
• Patient has received optimal medical management and it has been stable for 6 weeks prior to baseline testing. If pulmonary rehabilitation has been recent, it will be completed at least 3 months prior to baseline testing.
• Patient must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m.
• Patient has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study.
• Severe dyspnea defined as a mMRC ≥ 2.
• Patient's obstructive disease is severe as defined by:

• FEV1 ≤ 45% of predicted
• Patient's hyperinflation is defined by:

• TLC ≥ 100% of predicted
• 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.
• Investigator has confirmed that medical management is within standard of care and patient has been stable and without a COPD exacerbation for 6 weeks or more.

Exclusion criteria

• Patient has severe gas exchange abnormalities as defined by:

• PCO2 > 50 mm Hg (6.6 kPa), or
• PaO2 < 45 mm Hg (6.0 kPa) on room air
• Patient has a BMI < 15 kg/m2 or > 35 kg/m2
• Patient is unable to provide informed consent.
• Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
• Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
• Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year or has had a COPD exacerbation in the 3 months prior to baseline testing.
• Patient has bronchitis with sputum production > 60 ml per day.
• Patient has an active asthma component to their disease or requires more than 15 mg of prednisone daily (20 mg prednisolone).
• Patient has giant bulla (> 1/3 volume in either lung).
• Patient has severe pulmonary hypertension based upon clinical evaluation.
• A patient with a malignant condition and/or a life threatening disease (other than COPD) that would likely affect the completion of the study
• Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints. This would include neurological or musculoskeletal conditions that may interfere with testing.
• Patient has had prior lung volume reduction surgery or major lung procedures (lobectomy or greater).
• Patient has a lung nodule anticipated to require evaluation or intervention during the 3 month study period.
• Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
• Patient has a diffuse emphysema pattern, diffuse pulmonary fibrosis, or pulmonary tuberculosis (active, extensive, or with adhesive pleural incrassation).
• Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.
• 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.
• Female patient of childbearing potential has a positive result from a pregnancy test required during the 7 days prior to the procedure.