Home » AirXpanders Files 510(k) Submission for Breast Tissue Expander
AirXpanders Files 510(k) Submission for Breast Tissue Expander
AirXpanders Inc. has filed its 510(k) submission with the FDA for the AeroForm tissue expander, a wireless device for patients who choose to have reconstructive surgery following a mastectomy.
The expander is placed underneath the chest muscle, with the goal of stretching the tissue of the chest wall to make room for a permanent breast implant. It achieves tissue expansion through a controlled delivery of small amounts of carbon dioxide.
The Palo Alto, Calif.-based company announced in August that a study of the device had met its primary endpoint in patients who have undergone a mastectomy.
AirXpanders is cleared for commercialization in Europe and in Australia. — Michael Cipriano
Upcoming Events
-
23Apr
-
25Apr
-
07May
-
14May
-
30May