CONTROLLING PROLONGED AIR LEAKS

*INDICATION FOR USE: The Spiration 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 post-operative 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. Spiration Valve System use is limited to 6 weeks per prolonged, postoperative air leak.

CAUTION: Humanitarian Use Device for prolonged, postoperative Air Leaks. 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 air leaks, following lobectomy, segmentectomy, or Lung Volume Reduction Surgery (LVRS). The effectiveness of this device for this use has not been demonstrated. Federal law restricts this device to sale by or on the order of a physician.