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