- Western Europe
- Eastern Europe
- Asia and Oceania
- Middle East
Summary of Clinical Data
During a clinical study for a different use of the Spiration Valve, 4 patients were treated for air leaks. This is called “compassionate use” and is allowed by the Food and Drug Administration (FDA) when no other treatment is available.
Sixteen valves were placed in the 4 patients; so the average number of valves per patient was 4. All 4 patients had an immediate decrease or end to their air leak. No problems related to the device were reported. See Table 1 below for a summary of the problems related to the procedure.
Table 1: Procedure-Related Problems in Compassionate Use Patients
|Inflamed tissue||1 out of 4 patients and 16 valves||During the procedure to remove the valves, a very small amount of airway tissue inflammation was seen.|
|Ventilator support||1 out of 4 patients||After the procedure, a patient required assistance with breathing (mechanical ventilation) for less than 24 hours.|
Active Clinical Trials: EMPROVE Clinical TrialThe IBV Valve System for Treating Emphysema is Investigational and Not Approved in the United States.
In the United States, the IBV Valve System is not approved by the FDA for the treatment of emphysema, but is subject to ongoing clinical investigation in which approval for emphysema will be sought.
CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.