Evaluation of the IPS System for TLD Therapy in Patients With COPD

• FEV1 30% to 60%
• Patient is diagnosed with COPD
• Positive relative change in FEV1 of greater than 15%
• Patient 40 years of age or older at the time of consent
• Smoking history of at least 10 pack years
• Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria:

• Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
• Documented history or current evidence of congestive heart failure
• Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
• Patient has a PaCO2 > 8.0 kPa (60 mm Hg)
• Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
• Pulmonary nodule requiring surgery
• History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
• Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)