Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion

Inclusion Criteria:

1. Subject is willing and able to provide informed consent and to participate in thestudy.

2. Subject is ≥ 40 years of age.

3. Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (Global Initiative for Obstructive Lung Disease (GOLD) classification).

4. Subject has a post bronchodilator 15% ≤ FEV1 ≤ 50%.

5. Subject has Total Lung Capacity (TLC) ≥ 100% predicted.

6. Subject has Residual Volume (RV) ≥ 150% predicted.

7. Subject has a normal dobutamine stress echocardiogram.

8. Subject has sufficient exercise tolerance i.e. 150m ≤ 6MWT ≤ 450m.

9. Subject has an incomplete lobar fissure i.e. < 90%, as confirmed by CT evaluation oflung fissures.

10. Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmedduring first procedure/operation)

11. Subject has stopped smoking for at least 8 weeks prior to entering the study asconfirmed by carboxyhaemoglobin or cotinine levels.

12. Subject is up to date with preventive vaccinations including seasonal influenzavaccine and pneumococcal vaccine consistent with the Victorian Department of Healthand Human Services Immunization Schedule Guidelines (updated March 2018).

Exclusion Criteria:

1. Subject has a history of previous thoracotomy, lung volume reduction surgery, priorlobectomy or pneumonectomy, prior lung transplantation, prior airway stentplacement, prior pleurodesis, or prior endobronchial lung volume reduction therapyof any form.

2. Subject has an acute COPD exacerbation.

3. Subject has evidence of active respiratory infection.

4. Subject has a post bronchodilator FEV1 < 15%.

5. Subject has a Diffusing capacity for carbon monoxide (DLCO) < 20%.

6. Subject has a history of recurrent clinically significant respiratory infections,defined as three (3) or more COPD exacerbations requiring hospitalization during the 12 months prior to study enrollment (Informed Consent Form signature page).

7. Subject has severe gas exchange abnormalities as defined by any one of thefollowing:

8. Partial pressure of oxygen (PaO2) < 60 mmHg

9. Partial pressure of carbon dioxide (PaCO2) > 45 mmHg

10. Oxygen saturation (SpO2) < 90% on ≥ 4 L/min supplemental O2 at rest

11. Subject use of systemic steroids > 20mg/day or equivalent and/or immunosuppressiveagents in the 4 weeks prior to procedure.

12. Subject unable to temporarily interrupt use of heparins or oral anticoagulants orantiplatelet agents, excluding aspirin.

13. Subject's pre-operative CT scan indicates the presence of any of the followingradiological abnormalities:

14. Pulmonary nodule ≥ 0.8 cm in diameter (does not apply if present for 2 years ormore without increase in size or if proven benign by biopsy/positron emissiontomography (PET)).

15. Radiological picture consistent with active pulmonary infection, e.g.unexplained parenchymal infiltrate.

16. Giant bullae > 30% of the volume of either lung.

17. Significant interstitial lung disease.

18. Significant pleural disease.

19. Subject's baseline electrocardiogram (ECG) demonstrates clinically significantarrhythmias or conduction abnormalities.

20. Clinically significant asthma (reversible airway obstruction), chronic bronchitis orbronchiectasis.

21. Subject has a known diagnosis of alpha-1 antitrypsin deficiency.

22. Subject is classified as having "likely" pulmonary hypertension defined as tricuspidregurgitation velocity > 3.4m/s and/or pulmonary artery peak systolic pressure > 45mmHg on echocardiogram or a previous formal diagnosis of pulmonary hypertension onright heart catheterization.

23. Subject has suspected significant coronary artery disease defined as regional wallmotion abnormalities on dobutamine stress echocardiogram.

24. Subject is classified as being at major cardiac risk with the presence of unstablecoronary syndromes (i.e. unstable or severe angina or recent myocardial infarct),decompensated heart failure, significant arrhythmias or severe valvular disease,which warrants intensive management of the condition in accordance with currentguidelines on perioperative cardiovascular risk.