A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

Exclusion Criteria

• •1. Currently participating in another clinical study
• •2. Women of child-bearing potential
• •3. More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening
• •4. Any COPD exacerbations within 6 weeks of planned intervention
• •5. Two or more instances of pneumonia episodes in the last year at screening
• •6. Clinically significant mucus production or chronic bronchitis
• •7. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
• •8. Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
• •9. Clinically significant bronchiectasis
• •10. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days
• •11. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \> 45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit)
• •12. Suspected pulmonary nodule or lung cancer
• •13. High Resolution Computed Tomography (HRCT) collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
• •1. Large bullae encompassing greater than 30% of either lung
• •2. Insufficient landmarks to evaluate the CT study using the software as it is intended
• •3. All lobes are less than 25% parenchyma diseased (\< -950 HU)
• •14. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
• •15. Total Lung Capacity (TLC) \< 100% predicted at screening
• •16. Diffusing Capacity of Carbon Monoxide (DLCO) \< 15% or \> 50% of predicted value at screening
• •17. Partial pressure of carbon dioxide (PaCO2) \> 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening
• •18. Partial pressure of oxygen (PaO2) \< 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening
• •19. Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \> 2.5% at screening
• •20. Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study