-
2024
First CV+ Patient Treated in the CONVERT II Pivotal Trial
CONVERT II is a multicenter, international study evaluating the safety and effectiveness of the AeriSeal® System in limiting collateral ventilation in severe COPD/emphysema patients.
-
2024
Over 40K Patients Treated
More than 40,000 patients globally have been treated with Zephyr® Valves for their severe COPD/emphysema.
-
2021
Broad Insurance Coverage
Surpassed 200 million lives under insurance policies covering endobronchial valve(s) including Zephyr Valves.
-
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
-
FDA Breakthrough Device designation.
- 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 Valve RCT using Chartis System 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 Reports launched.
-
2015
Patient Milestones Achieved
- The New England Journal of Medicine publishes the results of the STELVIO trial, which utilized Chartis® System 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 Valve), BeLieVeR-HIFi.16
-
2014
Aeris Therapeutics Acquisition
Acquisition of Aeris Therapeutics assets, including AeriSeal® System.
-
2013
Chartis System Multicenter Trial Published
European Respiratory Journal publishes Chartis System multicenter trial demonstrating ability to predict Zephyr Valve responders.33
-
2010
First Zephyr Valve Randomized Clinical Trial Published
New England Journal of Medicine publishes first randomized trial of Zephyr Valve.17
-
2009
CE Mark for Chartis System
The Chartis System receives CE Mark.
-
2003
CE Mark for Zephyr Valve
The Zephyr Valve receives CE Mark.
US-EN-2329-v1