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

Inclusion Criteria:

1. Signed Informed Consent

2. Diagnosis of COPD/emphysema

3. Age 40 to 75 years

4. Body Mass Index (BMI) less than 30 kg/m2

5. 6-minute walk Distance between 100 meters and 500 meters at baseline exam

6. Stable disease with less than 10 mg prednisone (or equivalent) daily

7. Non-smoking for 4 months prior to screening interview

8. FEV1 between 15% and 50% of predicted value at baseline exam

9. FEV1/Forced Vital Capacity (FVC) < 70%

10. RV > 175%

11. mMRC score ≥ 2

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 atscreening

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 6months 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 7days

11. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure > 45 mmHg) 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 withinthe last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:

14. Large bullae encompassing greater than 30% of either lung

15. Insufficient landmarks to evaluate the CT study using the software as it isintended

16. All lobes are less than 25% parenchyma diseased (< -950 HU)

17. Any cardiac comorbidity which the PI believes would compromise the safety of thepatient after an IAB implant

18. Total Lung Capacity (TLC) < 100% predicted at screening

19. Diffusing Capacity of Carbon Monoxide (DLCO) < 15% or > 50% of predicted value atscreening

20. Partial pressure of carbon dioxide (PaCO2) > 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening

21. Partial pressure of oxygen (PaO2) < 45 mm Hg or Denver scale less than 30 mm Hg onroom air at screening

22. Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobecapillary) > 2.5% at screening

23. Any other conditions, which, in the opinion of the Investigator, would make thepatient unsuitable for inclusion, or could interfere with the patient participatingin or completing the study