Benefits & Risks
Zephyr Valve Treatment is Clinically Proven Safe and Effective Across Multiple Endpoints Out to At Least One Year
Zephyr Treatment Leads to Improved Health Status
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).
The Zephyr Valve is clinically proven safe and effective in patients with either heterogeneous or homogeneous emphysema.
| Randomized Controlled Trials | Sample size & follow-up period | Difference EBV vs Control Groups (ITT) | ||
| LUNG FUNCTION (FEV1%) | EXERCISE CAPACITY (6MWD) | QUALITY OF LIFE (SGRQ) |
||
| LIBERATE1 2:1 Randomization Heterogeneous only | n=190 12 months | 18.0% | 39 m | -7.1 pts |
| TRANSFORM9 2:1 Randomization Heterogeneous only | n=97 6 months | 29.3% | 79 m | -6.5 pts |
| IMPACT10 1:1 Randomization Homogeneous only | n=93 6 months | 16.3% | 28 m | -7.5 pts |
| STELVIO11 1:1 Randomization Heterogeneous & Homogeneous | n=68 6 months | 17.8% | 74 m | -14.7 pts* |
*Completed Cases
Hear From an Expert
“The hope was we could place valves in the most affected regions of the lungs to allow the air to come out of those lobes and allow the better quality of the lung to expand in the chest and function better.”
Risks
Complications of the Zephyr Endobronchial Valve Treatment include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.