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).
First and only endobronchial valve clinically proven safe and effective in patients with either heterogenous or homogenous 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 Heterogenous only | n=190 12 months | 18.0% | 39 m | -7.1 pts |
| TRANSFORM9 2:1 Randomization Heterogenous only | n=97 6 months | 29.3% | 79 m | -6.5 pts |
| IMPACT10 1:1 Randomization Homogenous only | n=93 6 months | 16.3% | 28 m | -7.5 pts |
| STELVIO11 1:1 Randomization Heterogenous & Homogenous | n=68 6 months | 17.8% | 74 m | -14.7 pts* |
*Completed Cases
Hear From an Expert
“At 3 months they [patients] get all their improvement in lung function, but their exercise tolerance continues to improve to 6 months and to a year afterward because of the reconditioning effect.”
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.