AirXpanders Receives FDA Clearance for Modified AeroForm Tissue Expander

The company has received FDA marketing clearance for an enhanced film material used to contain the CO2 within the device.

AeroForm is activated by a handheld wireless controller that administers small amounts of carbon dioxide (CO2) up to three times a day, to gradually stretch the tissue to prepare for a breast implant.

The device is used as a needle-free alternative for women who choose reconstructive surgery following a mastectomy.

AeroForm received de novo clearance from the FDA in December 2016. — Cynthia Jessup