Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema

Inclusion criteria

• Diagnosis of COPD
• FEV1/FVC ≤ 70%
• ≥ 40 years of age
• Post-bronchodilator FEV1 ≤ 45% of predicted
• Total Lung Capacity > 100% of predicted
• Residual Volume (RV) > 175% of predicted
• RV/TLC > 55%
• Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4
• Emphysema with ≥ 20% destruction (on -950 Hounsfield units) of two potential treatment lobe(s)
• Stopped smoking for ≥ 6 months prior to entering the study
• Completed a pulmonary rehabilitation program prior to entering the study and/or have regular (at least once a week) physiotherapy
• Ability to read, understand and sign the informed consent form

Exclusion criteria

• History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 2 hospitalizations for respiratory infections and/or COPD exacerbations during the year prior to enrolment
• History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 3 courses of prednisolone and/or antibiotics for respiratory infections and/or COPD exacerbations during the year prior to enrolment
• Clinically significant bronchiectasis
• Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg) and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
• ≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
• Inability to walk > 140 meters in 6 minutes
• Known pulmonary hypertension defined by right ventricular systolic pressure > 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram
• Significant paraseptal emphysema
• Giant bullae (>1/3 of lung volume)
• Medical history of asthma
• Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
• Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted)
• Evidence of other disease(s) that have a predicted survival of less than one year
• Inability to tolerate bronchoscopy under general anaesthesia
• Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy (such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be permanently stopped prior to entering the study
• Pregnant, lactating or plans to become pregnant within the study timeframe
• Known sensitivity to drugs required to perform bronchoscopy under general anaesthesia
• Any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments or in the judgment of the investigator would potentially interfere
• Known Nickel, Titanium, or Nitinol allergy