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Uptake Medical Receives CE Mark for InterVapor - Endoscopic Lung Volume Reduction for Treatment of Severe Emphysema - and Announces Positive Clinical Results
Date:9/26/2011

AMSTERDAM and TUSTIN, Calif., Sept. 26, 2011 /PRNewswire/ -- Uptake Medical® today announced it has received the CE Mark (Conformite Europeenne) for the InterVapor™ System - the first endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body's natural healing processes without leaving foreign materials behind. The CE Mark will allow Uptake Medical to commercialize InterVapor in key markets within the European Community.

This announcement coincides with the presentation of the six-month results from the worldwide, multi-center VAPOR trial at the European Respiratory Society Annual Congress. The clinical trial data shows significant improvement in breathing capacity, shortness of breath, exercise capacity and quality of life. The results of this trial were presented during clinical sessions at the European Respiratory Society's Annual Congress on Sunday, September 25, 2011 at 10:45 AM in Amsterdam.

Emphysema is a progressive disease in which the lungs are permanently damaged. This leads to a condition called hyperinflation, which impacts breathing function and forces patients to take short, shallow breaths, severely impacting quality of life. The InterVapor System was developed in response to the needs of patients with severe emphysema and is designed to directly target the hyperinflation in the lungs.

The VAPOR study was an open label, single-arm trial of InterVapor (Bronchoscopic Thermal Vapor Ablation) in patients with upper lobe predominant emphysema. Primary endpoints measuring lung function improvement (FEV1) and health-related quality of life (St. George's Respiratory Questionnaire or SGRQ) achieved both statistical and clinical significance at six months.  Additionally, 83 percent of patients met a combined endpoint for clinical improvement.  

Efficacy was consistently demonstrated across all endpoints. Secondary endpoints demonstrated that patients treated with the Inte
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