Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

This will be a prospective, multicenter, randomized, controlled study comparing outcomes
between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment)
to Control ratio of 1:1. The randomization will be stratified by homogeneous versus
heterogeneous emphysema, to support a balance of patients with differing heterogeneity in
both the LVRC and Control Groups.

Inclusion Criteria:

- Subject is greater than or equal to 35 yrs of age

- CT Scan indicates bilateral emphysema

- Subject has post-bronchodilator FEV1 less than or equal to 45% predicted

- Subject has Total Lung Capacity >100% predicted

- Subject has residual volume (RV) greater than or equal to 175% predicted

- Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4

- Subject has stopped smoking for at least 8 weeks prior to entering the study as
confirmed by a Cotinine test or other appropriate diagnostic test.

- Subject has completed a pulmonary rehabilitation program within 6 mos prior to
treatment and/or is regularly performing maintenance respiratory rehabilitation if
initial supervised therapy occurred more than 6 mos prior to baseline testing.

- Subject has received Pneumococcal and Influenza vaccinations consistent with local
recommendations and/or policy.

- Subject (and legal guardian, if applicable) has read, understood, and signed the
Informed Consent form.

Exclusion Criteria:

- Subject has severe homogeneous emphysema determined by Core Radiology Lab.

- Subject has co-morbidities that may significantly reduce subject's ability to improve
exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline
limitation on 6MWT is not due to dyspnea.

- Subject has a change in FEV1 of greater than 20% (or, for subjects with
pre-bronchodilator FEV1 below 1L, a change of greater than 200mL) post-bronchodilator
unless investigator can confirm by other means that subject does not have asthma.

- Subject has DLCO of less than 20% of predicted.

- Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of
less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg).

- Subject has a history of recurrent clinically significant respiratory infections,
defined as 3 hospitalizations for respiratory infection during the year prior to
enrollment.

- Subject as severe pulmonary hypertension defined by right ventricular systolic
pressure of greater than 50mm Hg and/or echocardiogram

- Subject has an inability to walk >140m (150 yd) in 6 minutes

- Subject has evidence of other severe disease (such as but not limited to lung cancer
or renal failure), which in the judgment of the investigator may compromise survival
of the subject for the duration of the study.

- Subject is pregnant or lactating, or plans to become pregnant within the study
timeframe.

- Subject has an inability to tolerate bronchoscopy under moderate sedation or general
anesthesia.

- Subject has clinically significant bronchiectasis.

- Subject has giant bullae >1/3 lung volume

- Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices
in either lung.

- Subject has been involved in pulmonary drug or device studies within 30 days prior to
this study.

- Subject is taking >20mg prednisone (or equivalent dose of a similar steroid) daily.

- Subject requires high level chronic immunomodulatory therapy to treat a moderate to
severe chronic inflammatory autoimmune disorder.

- Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as
Heparin or Coumadin) which cannot be stopped for 7 days prior to the procedure.

- Subject has 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 with
compliance to this study or would adversely affect study outcomes.

- Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent
metals.

- Subject has a known sensitivity to drugs required to perform bronchoscopy.

- Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).