>100 Scientific Articles Published 

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

Clinical Evidence
  • 4 RCTs published using Zephyr Valve and Chartis® to preselect patients1-5
  • Published in the New England Journal of Medicine, The Lancet, and The American Journal of Respiratory and Critical Care Medicine1-5,16
  • Statistically significant and clinically meaningful improvements compared to standard of care in multiple trials1-4
  • Treatment success seen in a broad range of primary and secondary endpoints1-5

Consistent Clinical Findings Across Four Randomized Controlled Trials

RCTDesignSample size & follow-up periodProcedural Success (TLVR%)Difference Zephyr Valve vs. Control Groups (ITT)
Lung
function
(fev1%)
MCID = 10%-15%
Excercise capacity
(6mwd)
MCID = 26 m
quality
of life
(sgrq)
MCID = -4 pts
LIBERATE12:1 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
TRANSFORM22:1 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
IMPACT31:1 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
STELVIO4,51:1 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 PMX (not in publication)
**Completed cases, all other values listed are ITT population
T Difference between valve and control groups
Clinical Evidence
*Completed cases, all other values listed are ITT population
Clinical Evidence

FEV1 Percent Change
from Baseline to 12 Months

LIBERATE - FEV1 - Percent Change - Gray Background | amCharts

Published in The American Journal of Respiratory and Critical Care Medicine1

The benefits are comparable to those seen with LVRS (lung volume reduction surgery) but with a reduction in post-procedure morbidity.”

  • Multicenter, multinational, randomized controlled trial
  • Results out to 12 months
  • Heterogeneous emphysema with little to no collateral ventilation
  • Clinically meaningful and statistically significant benefits over current standard of care medical therapy
  • Improvements in:
    • Lung function
    • Exercise tolerance
    • Dyspnea
    • Quality of life

Published in The American Journal of Respiratory and Critical Care Medicine2

Benefits are in line with those seen with LVRS (lung volume reduction surgery), and the consistent trial results, potential reduction in post-procedure morbidity, and reversibility of the procedure position Zephyr treatment as a viable treatment option in those who remain symptomatic on maximal medical therapy.”

  • Multicenter, multinational, randomized controlled trial
  • Heterogeneous emphysema with little or no collateral ventilation
  • Clinically meaningful and statistically significant benefits over current standard of care medical therapy
  • Improvements in:
    • Lung function
    • Exercise tolerance
    • Dyspnea
    • Quality of life
Clinical Evidence

FEV1 Percent Change
from Baseline to 6 Months

TRANSFORM - FEV1 - Percent Change | amCharts

Clinical Evidence

FEV1 Percent Change
from Baseline to 6 Months

IMPACT - FEV1 - Percent Change - Gray Background | amCharts

Published in The American Journal of Respiratory and Critical Care Medicine3

EBV therapy in selected patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life. Given the very limited treatment options available for this patient population, EBV therapy should be considered in these patients.”

  • Prospective randomized controlled trial
  • Homogeneous emphysema with little or no collateral ventilation
  • Clinically meaningful benefits in:
    • Lung function
    • Exercise tolerance
    • Quality of life

Published in The New England Journal of Medicine4

Endobronchial valve treatment in patients with emphysema and a proven absence of interlobar collateral ventilation provided a measurable clinical benefit, with significantly improved lung function, exercise capacity, and quality of life as compared with usual care.”

  • Prospective randomized controlled trial
  • First randomized study to use Chartis® to pre-select candidates
  • Emphysema with little or no collateral ventilation
  • Statistically and clinically greater improvements than the control group for:
    • Pulmonary function (FEV1 and FVC)
    • Exercise capacity
    • Quality of life
  • One-year follow-up published in The American Journal of Respiratory and Critical Care Medicine5

Clinical Evidence

FEV1 Percent Change
from Baseline to 6 Months

STELVIO - FEV1 - Percent Change - White Background | amCharts

International Guidance Documents Include Endobronchial Valve Treatment as an Option for Emphysema Patients

Multiple independent networks have concluded that with proper patient selection, the Zephyr Valve procedure should be considered in the treatment of severe emphysema.

The quality of evidence for treatment with endobronchial valves has been graded “A” by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).10

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has included this treatment as part of standard measures for COPD and recommended all qualifying patients be evaluated for eligibility.11,34

Patient Treatment Preference

A detailed survey of 294 severe emphysema patients evaluated how they balance potential risks and benefits. The study concluded that patients with severe emphysema value access to an interventional treatment that offers benefits above and beyond their current medical management, despite the risks associated with these treatments.8

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