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Since 2008, the Spiration® Valve System has been approved by the FDA as a Humanitarian Use Device for the control of prolonged air leaks following specified lung resections.*

 

Spiration® Valve System Intended Use

Intended Use

The Spiration Valve System is intended to control prolonged air leaks (see definition below) 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 
  • (a segmentectomy) or 
  • a major surgery in which multiple portions of the lung are removed (Lung Volume Reduction Surgery or LVRS). 

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.
 

When the Spiration Valve System Should Not Be Used (Contraindications)

Your doctor will not place a Spiration Valve in your lungs if you are unable to have a narrow, flexible tube (bronchoscope) placed through your nose or mouth and into your lungs. If you suspect or know that you are allergic to nickel, let your doctor know. You should not have a Spiration Valve placed in your lungs.