Redwood City, Calif. – October 5, 2016 – Pulmonx, a leader in interventional pulmonology, today announced completion of enrollment in its pivotal IDE study – the LIBERATE Trial – a randomized, controlled, multi-center study of the Zephyr® Endobronchial Valve (EBV) in patients with severe emphysema, a form of chronic obstructive pulmonary disease (COPD). Results from the LIBERATE Trial will support approval of the device for use in the U.S.
Zephyr EBVs are tiny, minimally-invasive, one-way valves placed in select airways of the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions may function more efficiently, enabling better breathing and an improved quality of life for patients.
The LIBERATE Trial enrolled 190 patients at 24 centers to evaluate the safety and effectiveness of the Zephyr EBV versus optimal medical management, with patients randomized 2:1 Zephyr EBV versus control. The primary outcome to be evaluated at one year is Forced Expiratory Volume in one second (FEV1, an objective measure of breathing function). Secondary outcomes are volume reduction of the treated lobe of the lung, the Six Minute Walk Distance (6MWD, a measure of exercise tolerance) and the St. George’s Respiratory Questionnaire (SGRQ, a measure of quality of life).
“The Zephyr EBV is the most studied endoscopic lung volume reduction device globally and is considered first-line therapy by leading physicians outside of the U.S.,” said Pulmonx Chief Executive Officer Glen French. “Completing enrollment in this important trial moves us one step closer to making this proven treatment available to U.S. patients who have few options today.”
Three randomized controlled trials of the Zephyr EBV conducted outside of the U.S. (BeLieVeR-HIFi, STELVIO and IMPACT) provide a significant body of evidence supporting the device’s ability to significantly improve lung function, exercise tolerance and quality of life in patients with no collateral ventilation, as assessed with the Chartis System.1,2,3,4 Published clinical data also demonstrate sustained patient benefits out to five years5 and potential survival benefits at five and 10 years post-treatment,6,7 indicating a possible slowing in disease progression.
More than 50 percent of severe emphysema patients have no collateral ventilation in one or more target lobes of the lung8,9 demonstrating a large potential market for the Zephyr EBV treatment. Over the past 10 years, more than 40,000 Zephyr EBVs have been implanted globally in more than 12,000 patients.
The Zephyr® EBV is an investigational device in the United States. Limited by U.S. law to investigational use.
- Klooster K, Ten Hacken NHT, Hartman JE, Kerstjens HAM, Van Rikxoort EM, Slebos DJ. Endobronchial Valves for emphysema without interlobar collateral ventilation. N Engl J Med 2015; 373:2325-233
- Davey C, Zoumot Z, Jordan S, McNulty W, Carr D, Hind M, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. The Lancet 2015.
- Sciurba FC, Ernst A, Herth FJF, Strange C, Criner G, Marquette C, et al. A Randomized Study of Endobronchial Valves for Advanced Emphysema. New Eng J Med 2010; 363: 1233-1244 (including supplementary appendix).
- Herth F, Noppen M, Valipour A, Leroy S, Vergnon J-M, Ficker JH, Egan E, Gasparini S, Agusti C, Homes-Higgin D, Ernst A on behalf of the International VENT Study Group. Efficacy predictors of endoscopic lung volume reduction with Zephyr valves in a European cohort with emphysema. Eur Respir J 2012; 39: 1334-1342.
- Venuta F, A Marco, D Daniele, Coloni G, et. al. Long-term follow-up after bronchoscopic lung volume reduction in patients with emphysema. Eur Respir J 2012; 39: 1084–1089.
- Hopkinson NS, Garner J, Kemp S, et al. Survival after Endobronchial Valve Placement for Emphysema: A 10-Year Follow-up Study Eur Respir J 2016; 519-521
- Gompelmann D, Benjamin N, Bischoff E et al. Survival after endoscopic valve therapy in patients with severe emphysema Eur Respir J 2016 (ERS 2016 Abstract #OA472)
- Herzog D, Dollinger F, Pollinger A et al (2014). New COPD subgroups according to prevalence and distribution of Interlobar Collateral Ventilation assessed by an Endobronchial Catheter System. First published online May 01, 2014 as doi:10.1164/ajrccm-conference.2014.189.1_Meeting Abstracts.A2430
- Koster TD, Rikxoort E, Slebos D, et al. Predicting Lung Volume Reduction after Endobronchial Valve Therapy Is Maximized Using a Combination of Diagnostic Tools Respiration 2016 (In press)
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