First in Human Study to Assess an Implant to Treat Severe Emphysema

Exclusion Criteria

• •1. Arterial blood PaCO2 \> 60 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
• •2. DLCO \<20% at screening
• •3. Steroid therapy of 10 mg prednisolone (prednisone) or more per day
• •4. Three or more acute exacerbations of COPD in the past year before enrollment
• •5. Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
• •6. Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure
• •7. Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant
• •8. Known history of pulmonary arterial hypertension
• •9. Presence of a giant bulla (≥ 30% of hemithorax)
• •10. History of excessive dynamic airway collapse of the trachea or main bronchi
• •11. History of adult asthma or chronic bronchitis
• •12. Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment
• •13. Unequivocal and symptomatic bronchiectasis
• •14. Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer
• •15. Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic \> 200 mmHg or diastolic \> 110 mmHg at screening or prior to first Apreo Procedure
• •16. Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding
• •17. On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure
• •18. Coronary artery disease with angina
• •19. History of myocardial infarction within 6 months
• •20. History of a stroke less than 1 year before the first Apreo Procedure
• •21. Clinical history of heart failure with documented LVEF ≤ 40%
• •22. Clinical history of diabetes with a HbA1c \> 9.0%
• •23. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney failure (Stage 5 kidney disease)
• •24. Mechanical ventilator dependence except participants using nocturnal bi-level positive airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if it would not preclude safe implantation of the study device
• •25. Pregnant, lactating, or women of childbearing potential who plan to become pregnant within the study duration
• •26. Known hypersensitivity to nitinol
• •27. Significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis
• •28. Any disease or condition likely to limit survival to less than one year
• •29. Concomitant illnesses or medications that may pose a significant increased risk for complications following an Apreo Procedure
• •30. Currently enrolled in another trial and actively receiving experimental treatment
• •31. Any condition in the opinion of the investigator that would interfere with safe and complete collection of study data including the safe conduction of bronchoscopy procedures