A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema

Prior treatment

• Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment
• More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
• Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening
• Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR)

Other illness

• Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening
• Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
• Suspected malignant pulmonary nodule or other lung cancer
• Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
• Current diagnosis of substance abuse disorder.
• Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder
• 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.

Lab values

• Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days

Other

• α-1 Antitrypsin deficiency
• Women of child-bearing potential
• Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
• Clinically significant mucus production or chronic bronchitis
• Clinically significant bronchiectasis
• 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:
  • Large bullae encompassing greater than 30% of either lung
  • Insufficient landmarks to evaluate the CT study using the software as it is intended
  • All lobes are less than 25% parenchyma diseased (\< -950 HU).
• TLC \< 100% predicted at screening
• DLCO \< 15% or \> 50% of predicted value at screening
• PaCO2 \> 50 mm Hg at screening
• PaO2 \< 45 mm Hg in room air at screening
• Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \>2.5% at screening.

• Signed Informed Consent
• Diagnosis of COPD/emphysema
• At least 22-years of age
• 18 ≤ BMI ≤ 32
• 6-minute walk Distance of between 100 - and 400 meters
• Stable disease with less than 10-mg prednisone (or equivalent) daily
• Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
• FEV1 between 15% and 45% of predicted value at baseline exam
• FEV1/FVC \<70%
• Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab.
• Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab.
• RV \> 175% of predicted value.
• mMRC score ≥ 2