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The Spiration IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to six weeks per prolonged air leak.
The Spiration IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS).
TABLE 1: IBV Valve Biocompatibility Testing and Results TABLE 2: Deployment Catheter Biocompatibility Testing and Results
Other
Adult
Modi, Aakash
Lung
National
BMDACC Clinical Trials Office
Directions for use: See the Physician's Labeling. Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions and Adverse Events in the labeling. Postapproval Requirements and Restrictions: See Approval Order.
H060002/Spiration IBV Valve
Humanitarian Device
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