IBV Valve System Approvals and Investigational Status
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 Use Device. Authorized by Federal (or United States) law for 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. 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
(1.2M pdf)
Instructions for Use, HDE, Airway Sizing Kit, IBV Valve System (700K pdf)
Instructions for Use, HDE, Airway Sizing Worksheet, IBV Valve System (1M pdf)
- CAUTION: Humanitarian Use Device. Authorized by Federal (or United States) law for 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. The effectiveness of this device for this use has not been demonstrated.
- The IBV Valve System is also currently under investigation in the U.S. as a new treatment option for patients with severe emphysema.
- A randomized, prospective, double-blind, controlled U.S. pivotal trial to evaluate safety and effectiveness of the IBV Valve System for the treatment of severe emphysema is currently enrolling patients.
- CAUTION: The IBV Valve System is not yet approved for use in emphysema, but is subject to an ongoing clincal investigation in which approval for use in emphysema will be sought. The IBV Vale is a Humanitarian Use Device authorized by Federal (or United States) law for 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. The effectiveness of this device for this use has not been demonstrated.
In Europe:
- The IBV Valve System has received market clearance through CE Mark for treatment of diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of air leaks .
- The device is marketed and distributed by Olympus Medical Systems in Europe.
In Japan:
- Olympus Medical Systems Corporation has development and distribution rights for the IBV Valve System in Japan.
In Canada:
- The IBV Valve 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.