AirXpanders, a Palo Alto, California firm, has been cleared to bring its AeroForm tissue expander to European women undergoing breast reconstruction post mastectomy. The device, which allows women to inflate the implant at a desired rate, rapidly speeds up the expansion process and makes unnecessary regular trips to the clinic for uncomfortable saline injections.
Using a remote control, a women essentially turns a valve on a built-in CO2 canister within the implant, releasing the gas into the flexible chamber. The AeroForm is currently in a clinical trial in the U.S. under FDA’s Investigational Device Exemption (IDE) with the hope of regulatory approval in the near future.
A current method of breast reconstruction involves tissue expansion followed by placement of a breast implant. In the traditional method for expansion, a surgeon places a saline tissue expander under the skin and pectoral muscle following the mastectomy. During subsequent office visits, the surgeon inserts a needle through the skin and muscle into a magnetic port to inject a bolus of saline into the expander to the level tolerated by the patient. The series of saline inflations needed to fill the expander, can take up to six months while the AeroForm has been shown to achieve full expansion in as little as 14 days, according to a study published in Plastic and Reconstructive Surgery in October of 2011.