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  • 2019

    GOLD Evidence "A" Rating

    GOLD’s evidence “A” rating affirms that endobronchial valves, like the Zephyr® Valve, are a viable, minimally–invasive treatment option for severe emphysema, a form of COPD.

  • 2019

    5.5-LP Approval

    Zephyr Valve 5.5-LP approved for use in the U.S.

  • 2018

    U.S. FDA Approval

    • FDA Approval of the Zephyr Valve in the United States.20
    • LIBERATE multi-center, multinational RCT results published in the Blue Journal demonstrating clinically meaningful and statistically significant benefits over the current standard of care medical therapy with improvements in lung function, exercise tolerance, quality of life, and dyspnea.
  • 2017

    Clinical Benefits

    Data from 2 multicenter RCTs presented showing significant clinical benefits for both heterogeneous and homogeneous emphysema patients without collateral ventilation.

    • GOLD includes Zephyr Valve in its COPD management recommendations.9
    • Respiration publishes positive 1-year outcomes from STELVIO, first Zephyr RCT using Chartis for patient selection.5
    • The Blue Journal publishes results of the TRANSFORM multi-center, multinational RCT which showed Zephyr Valve offered benefits similar to LVRS along with a potential reduction in post-procedure morbidity for patients who are symptomatic despite maximal medical therapy.
  • 2016

    Clinical Evidence Documented

    • The IMPACT RCT of patients with homogeneous emphysema is published in the Blue Journal, demonstrating clinically meaningful benefits for lung function, exercise tolerance and quality of life.3
    • StratX® Lung Analysis Platform launched.
  • 2015

    Patient Milestones Achieved

    • The New England Journal of Medicine publishes the results of the STELVIO trial, which utilized Chartis® to pre-select candidates for Zephyr Valve treatment and demonstrated statistically significant and clinical improvements in pulmonary function, exercise capacity and quality of life in the treated group over the standard of care.4
    • The Lancet publishes first successful sham-controlled trial of any minimally invasive emphysema device (Zephyr), BeLieVeR-HIFi.16
  • 2014

    Aeris Therapeutics Acquisition

    Acquisition of Aeris Therapeutics assets, including AeriSeal.

  • 2013

    Chartis Multicenter Trial Published

    European Respiratory Journal publishes Chartis multicenter trial demonstrating ability to predict Zephyr responders.33

  • 2010

    First Zephyr Randomized Clinical Trial Published

    New England Journal of Medicine publishes first randomized trial of Zephyr.17

  • 2009

    CE Mark for Chartis

    The Chartis System receives CE Mark.

  • 2003

    CE Mark for Zephyr