Clinical Evidence

The Zephyr^® Endobronchial Valve delivers clinical benefits — without surgery and its associated risks.^1-5 Zephyr Valve is the most studied endobronchial valve and has consistently been shown to be a safe and effective treatment for patients with severe COPD/emphysema.

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Results from multiple randomized clinical trials of the Zephyr Valve have demonstrated clinically meaningful benefits in lung function, exercise capacity, and quality of life (QoL).^1-5

RCTs published using Zephyr Valve and Chartis^® Pulmonary Assessment System to preselect patients^1-5
Published in the New England Journal of Medicine, The Lancet, and The American Journal of Respiratory and Critical Care Medicine^1-5,16
Statistically significant and clinically meaningful improvements compared to existing standard of care treatment in multiple trials^1-4
Treatment success seen in a broad range of primary and secondary endpoints^1-5

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RCT	Design	Sample size & follow-up period	Procedural Success (TLVR%)	Difference Zephyr Valve vs. Control Groups (ITT)
RCT	Design	Sample size & follow-up period	Procedural Success (TLVR%)	Lung function (fev₁%) MCID = 10%-15%	Excercise capacity (6mwd) MCID = 26 m	quality of life (sgrq) MCID = -4 pts
LIBERATE¹	2:1 Randomization Heterogeneous only Multicenter	n=190 12 months	84%	18.0% p<0.001	39 m p=0.002	-7.1 pts p=0.004
TRANSFORM²	2:1 Randomization Heterogeneous only Multicenter	n=97 6 months	90%	29.3% p<0.001	79 m p<0.001	-6.5 pts p=0.031
IMPACT³	1:1 Randomization Homogeneous only Multicenter	n=93 6 months*	89%	16.3% p<0.001	28 m p=0.016	-7.5 pts p<0.001
STELVIO^4,5	1:1 Randomization Heterogeneous & Homogeneous Single Center	n=68 6 months	88%	17.8% p=0.001	74 m p<0.001	-14.7 pts** p<0.001

*Data on file at Pulmonx (not in publication)

**Completed cases, all other values listed are ITT population

The table above summarizes the results of four randomized controlled trials on Zephyr Valves. Click on the name of a study for more information or click to view our Clinical Evidence Summaries.

Results from multiple randomized clinical trials of the Zephyr^® Valve have demonstrated clinically meaningful benefits in lung function, exercise capacity, and quality of life (QoL).^1-5

RCTs published using Zephyr Valve and Chartis^® to preselect patients^1-5
Published in the New England Journal of Medicine, The Lancet, and The American Journal of Respiratory and Critical Care Medicine^1-5,16
Statistically significant and clinically meaningful improvements compared to existing standard of care in multiple trials^1-4
Treatment success seen in a broad range of primary and secondary endpoints^1-5

Pulmonx-Zephyr-Clinical-Study-Summary-Table

*Completed cases, all other values listed are ITT population

**Completed cases, all other values listed are ITT population

Click here to view references.
For more information about these randomized controlled trials, click to view our Clinical Evidence Summaries.

Recent Clinical Data

2023 GOLD Report Summary

The 2023 GOLD Report highlights patient benefits resulting from Endobronchial Valve treatment.

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Study on Improved Survival

A single-center, retrospective study that found improved survival of 1.7 years after Zephyr Valve treatment.

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Study on Cardiac Output

A single-center, retrospective study that found improvements in cardiac output after Zephyr Valve treatment.

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US-EN-1834-v1