||one-way air-leak valve|
||To restrict air flow to the target section of the lung.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.
||This device is a small nitinol frame that has a polyurethane membrane over the Nitinol frame that acts as a plug to the targeted section of the lung.
||The device is a nitonal frame with a polyurethane membrane over the Nitinol frame. The valve does not allow air into the targeted segment of the lung, but does allow air and mucus out of that lung section.
||The device is intended to occlude a section of lung.
|| General & Plastic Surgery
Office of Device Evaluation
Division of Surgical Devices
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
HDE - Humanitarian Device Exemption
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible