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.
Zephyr Valve 5.5-LP approved for use in the U.S.
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.
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.
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.
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
Aeris Therapeutics Acquisition
Acquisition of Aeris Therapeutics assets, including AeriSeal.
Chartis Multicenter Trial Published
European Respiratory Journal publishes Chartis multicenter trial demonstrating ability to predict Zephyr responders.33
First Zephyr Randomized Clinical Trial Published
New England Journal of Medicine publishes first randomized trial of Zephyr.17
CE Mark for Chartis
The Chartis System receives CE Mark.
CE Mark for Zephyr