Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

The IBV Valve Trial is a multi-center clinical trial evaluating the IBV Valve System, a
non-surgical treatment for patients with emphysema. The IBV Valve System does not require
traditional surgery or surgical incisions. The valves are placed during a bronchoscopic
procedure. The IBV Valve System is designed to redirect airflow from diseased portions of the
lung to healthier areas to achieve improvement in disease-related health status. Although the
valves are intended to be permanent, they are designed to be removed if necessary.

The IBV Valve Trial is a randomized, blinded trial. This means that participants are divided
into two groups but do not know to which group they have been assigned.

The IBV Valve Treatment Group receives valves, and the Control Group does not. A random
selection process decides the group assignments (participants will not be able to choose
their group). In the trial, everyone will have a 50 percent chance (similar to a coin toss)
to be assigned to one group or the other.

All Participants in this Clinical Trial will:

Receive a diagnostic bronchoscopy that will allow an expert in lung health to evaluate their
lungs.

Be under the care of a highly qualified lung doctor for the entire time they are in the
trial, regardless of whether they are in the Treatment Group or the Control Group.

Receive regular periodic check-ups and health assessments throughout the 6 month trial
period.

The procedure, all testing, and doctor visits are provided at no cost to participants of both
the IBV Valve Treatment Group and the Control Group.

At the completion of their 6-month visit, participants will be told if they were assigned to
the Treatment Group or the Control Group. If participants were assigned to the group that did
not receive valves (the Control Group), they will be given the option to be re-evaluated by
the clinical trial doctor, to determine if they can have valve treatment.

Inclusion Criteria:

- Candidates have mostly upper lobe, severe emphysema.

- Must be able to participate in standard exercise testing.

- Willing to abstain from cigarette smoking for 4 months prior and during the entire
trial.

- Willing to participate in a randomized, blinded study and complete the required
follow-up visits during the study period.

- Willing to participate in multiple visits to a medical center for health assessment
tests.

- Willing to have a minimum of one overnight stay in the hospital.

Exclusion Criteria:

- Evidence of another co-existing major medical disease.

- Unable to tolerate, flexible bronchoscopy procedures.

- Active asthma, chronic bronchitis.

- Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.

- Has had prior lung volume reduction surgery.