The Food and Drug Administration on Thursday gave marketing clearance for the AeroForm tissue expander system.
The device, developed by Palo Alto, Calif.-based AirXpanders, is used to stretch out breast tissue in preparation for a two-stage breast reconstruction following a mastectomy. AeroForm can also be used to treat underdeveloped breasts and soft tissue deformities, according to a news release from the agency.
AeroForm is a balloon-like device that is implanted into a woman's breast and filled with saline or air. When the device expands, it gradually stretches out breast tissue and muscle to create space for a breast implant.
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