Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

Inclusion criteria

• Patient greater than or equal to 35 years of age
• High resolution CT scan indicates unilateral or bilateral emphysema
• High resolution CT scan indicates homogeneous or heterogeneous emphysema
• Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
• Total Lung Capacity greater than 100% predicted
• Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
• Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
• Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion criteria

• Patient has a change in FEV1 greater than 20% post-bronchodilator
• Patients DLCO less than 20% predicted
• Patient has a history of recurrent clinically significant respiratory infection
• Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
• Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
• Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
• Patient is pregnant or lactating
• Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
• Patient has clinically significant bronchiectasis
• Patient has giant bullae greater than 1/3 lung volume
• Patient has had previous LVR surgery, lung transplant or lobectomy
• Patient has been involved in other pulmonary drug studies with 30 days prior to this study
• Patient is taking greater than 20 mg prednisone (or similar steroid) daily
• Patient is on Plavix or has not been weaned off prior to procedure
• Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes