BREATHING INNOVATION INTO LIFE

Transcription

1 BREATHING INNOVATION INTO LIFE

2 About Emphysema A Clinical Research Study for people with severe emphysema. Find out if this study may be Emphysema is a form of chronic obstructive pulmonary disease (COPD) that affects five million people in the US. The primary symptom of emphysema is shortness of breath. For some people, breathing becomes difficult even during routine activities, such as walking or eating. right for you. In emphysema, tiny air sacs in the lungs (called alveoli) break down and lose elasticity. Air gets trapped in the alveoli and the diseased region of the lung expands. As it expands, the diseased region compresses healthier regions of the lung making it difficult to breathe.

3 Healthy alveoli Damaged alveoli Healthy Lung Lung with Emphysema

4 Current Treatment Options Emphysema patients often use medication, supplementary oxygen and/or inhalers to improve their symptoms. However, many still have difficulty breathing. Today, severe emphysema patients have no alternatives except more invasive The Zephyr Endobronchial Valve is an investigational device that is intended to reduce the volume of the diseased region of the lung to allow healthier areas to In this minimally invasive procedure, Zephyr valves are placed in the diseased region of the lung. BEFORE TREATMENT The one-way valves block airflow into the diseased region (green arrows) and allow trapped air and fluids to escape (orange arrows). AFTER TREATMENT surgical procedures. function more efficiently, helping patients breathe better. ACTUAL SIZE With emphysema, air becomes trapped in the alveoli, causing hyperinflation, which compresses the healthier regions of the lung. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently.

5 Study Overview The LIBERATE Study is evaluating the Zephyr Endobronchial Valve in patients with severe emphysema. The Zephyr valve is an investigational device in the United States, which means that it has not been cleared by the Food and Drug Administration (FDA) for sale in the US. The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the Treatment group or to the Control group. The Treatment group will receive the Zephyr valve in combination with optimal medical therapy. The Control group will receive optimal medical therapy alone. For every three participants in the study, two will go into the Treatment group and one will go into the Control group. FOR PATIENTS WITH SEVERE EMPHYSEMA

6 Study Eligibility To qualify for this clinical study, you must meet the study eligibility requirements. If you are eligible and choose to participate in the study, you will be expected to attend all follow-up visits and participate in all follow-up examinations and tests with your doctor. Eligibility requirements include but are not limited to: Diagnosed with emphysema Non-smoking for at least 4 months before the screening examination Agree to participate in a pulmonary rehabilitation program, both before and after enrollment in the study HOW DO I QUALIFY? Willing to complete medical evaluations, including baseline tests and a bronchoscopic procedure If you are interested in the study please contact the study coordinator or doctor to discuss the full list of eligibility criteria and the potential benefits and risks associated with the LIBERATE Study.

7 Place Study Site Contact Information Here Pulmonx Corporation 700 Chesapeake Drive Redwood City, CA USA Tel: +1 (650) CAUTION: The Zephyr Endobronchial Valve is an investigational device in the US, limited by US law to investigational use. Copyright Pulmonx. All Rights Reserved. CL065_11FEB2015