Tests a airway implant device for breathlessness from emphysema in adults

Other criteria

• Inclusion Criteria; Subject is at least 40, but not older than 84, years of age; Subject has body mass index (BMI) of between 18 and 32, inclusive; Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline; Subject has mMRC score ≥ 2; Subject can walk ≥100 meters in 6 minutes; Subject has ≥25% emphysema destruction score in each lung as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the 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 (-910HU) as determined by the CT core lab; Subject has bilateral heterogenous emphysema and pre-procedure post-bronchodilator RV ≥ 180% predicted, or one lung with homogenous emphysema and pre-procedure postbronchodilator RV ≥ 200% predicted; Subject has pre-procedure post-bronchodilator FEV1/ FVC < 0.70; Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%; Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55; Subject has pre-procedure DLCO ≥ 20%; Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment; Subject has not actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 4 months, and agrees to smoking cessation during the study; Subject has received preventative vaccinations (or documented clinical intolerance) against potential respiratory infections, including pneumococcus, influenza, RSV (subjects >60 yrs. old) and Covid-19, consistent with local recommendations or policy; In the opinion of the Primary investigator, subject can undergo bronchoscopy under general anesthesia and is able to adhere to the study follow-up schedule; Subject has provided written informed consent
• Exclusion Criteria; Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis); Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day); Subject has bilateral lobar emphysematous destruction scores of >70% percent of voxels with <-950 Hounsfield units on thin slice inspiratory CT, as determined by the CT core lab; Subject has arterial or capillary blood on room air: PaCO2 > 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa); Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations/respiratory infections in the year prior to enrollment; Subject has had previous lung volume reduction surgery, lobectomy, pneumonectomy, segmentectomy, bullectomy, lung transplantation, vapor, glue, or other pulmonary device implant (unless the device has been removed at least 3 months prior to consent); Subject has known or suspected history of pulmonary arterial hypertension (e.g. PASP > 50mmHg on echocardiogram in absence of confirmation on a right heart catheterization or mPAP > 25mmHg on a right heart catheterization); Subject has presence of a giant bulla (≥ 30% of hemithorax); Subject has significant symptom burden due to currently active adult asthma based on GINA criteria and/or chronic bronchitis as their primary diagnosis; Subject has presence of suspicious radiological abnormalities on HRCT scan such as pulmonary nodule/infiltrate that in judgement of the PI, may require intervention during course of the study; Subject has clinically significant bronchiectasis (>4 TBS / 45mL mucus production/day, per subject estimate) influencing subject's COPD symptoms; Subject has unresolved lung cancer; Subject has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy (documented LVEF ≤40%), or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension (diastolic BP >110 mmHg or systolic >200 mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy; Subject is on anticoagulant or antiplatelet therapy for cardiovascular indications and, at the discretion of the Primary investigator, is unable to have anticoagulants withheld for a bronchoscopy procedure per institution's standard of care; Subject has invasive mechanical ventilator dependency; Subject is pregnant, lactating, or of childbearing potential and plans to become pregnant during study duration; Subject has known hypersensitivity to Nitinol (nickel-titanium alloy) or its constituent metals (nickel or titanium); Subject is significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis; Subject has sensitivity or allergy to medications necessary for bronchoscopy under general anesthesia; Subject is currently participating in another study involving an investigational product that could confound the study results or affect the subject's COPD symptoms; Subject has within the 2 years prior to consent, had a severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation