Cautionary Statements, Approvals and Investigational Status of the IBV Valve System

In the United States:

• The IBV Valve System has received Humanitarian Device Exemption (HDE) approval to control prolonged air leaks of the lung or significant air leaks that are likely to become prolonged following lobectomy, segmentectomy or lung volume reduction surgery.
  
  
  • CAUTION: Humanitarian Device. Authorized by Federal Law for use in the control of prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). The effectiveness of this device for this use has not been demonstrated.
    
    
  • CAUTION: Federal law restricts this device to sale by or on the order of a physician.
    
    
  • FDA HDE Approval Documents:
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=H060002  
    
    
  • HDE Instructions for Use Downloads:
    Instructions for Use, HDE, IBV Valve System (pdf) 
    Instructions for Use, HDE, Airway Sizing Kit, IBV Valve System (pdf) 
    Instructions for Use, HDE, Airway Sizing Worksheet, IBV Valve System (pdf) 

• The IBV Valve System is also currently under investigation in the U.S. as a new treatment option for patients with severe emphysema.

• CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

In Europe:

• The IBV Valve System has received market clearance through CE Mark.
  
• INTENDED USE: The IBV Valve System is a device placed in the lung airway intended to treat diseased lung in emphysematous patients or damaged lung resulting in air leaks by limiting airflow to selected areas.

In Australia and New Zealand:

• The IBV Valve System was registered and approved by the Therapeutic Goods Administration in Australia and by MEDSAFE in New Zealand.
  
  
  • INTENDED USE: The IBV Valve System is a device placed in the lung airway intended to treat diseased lung in emphysematous patients or damaged lung resulting in air leaks by limiting airflow to selected areas.

In Japan:

• Plans to obtain regulatory approval for the IBV Valve System are underway.

In Canada:

• The IBV Valve System is an investigational device in Canada.

• CAUTION: The IBV Valve System is an investigational device for the treatment of severe emphysema and is limited by federal law to investigational use.