Respiratory/Pulmonary Disease
IBV® Valve System, a Humanitarian Use Device Intended to Control Prolonged Air Leaks
Description
The IBV® Valve System is approved by the FDA as a Humanitarian Use Device for prolonged air leaks of the lung following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS).
Inclusion Notes
The Spiration Valve System is intended to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following:
• surgery to remove a lobe of the lung (a lobectomy),
• surgery to remove a segment, or small portion, of the lung or
• a major surgery in which multiple portions of the lung are removed.
If you still have an air leak 7 days after your surgery, you have a prolonged air leak, unless the leak is there only when you:
• forcefully blow out air (forced exhale — this is done to see if you have an air leak) or
• cough.
You can be considered for a Spiration Valve placement if you have an air leak 5 days after surgery and if the air leak is:
• continuous,
• present when you breath in normally (not forced), or
• present when you breath out normally (not forced) and you have either trapped air under the skin (subcutaneous emphysema) or difficulty breathing (respiratory compromise).
Use of the Spiration Valve System is limited to 6 weeks for each prolonged air leak.
Start Date
Tuesday, October 18, 2011
Principal / Contact Name
Dr. O. B. Rheman