CE Mark For AirXpanders AeroForm™ Patient-Controlled Tissue Expander

In short

AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, has received European CE Mark approval for AeroForm™, a needle-free, patient-controlled tissue expansion system.


The eponymous AirXpanders, focuses on the area of breast cancer reconstruction, specifically the expansion of tissue following mastectomy in order to be able to accommodate a breast implant. By employing a revolutionary patient-controlled expander, activated by a wireless remote control, the often painful process can potentially be eased with this needle-free technology.

This technology is designed for ease of use and may enable the patient to proceed to a permanent implant much faster than the current standard-of-care which involves surgical placement of a saline tissue expander under the skin and pectoral muscle following the mastectomy. During subsequent office visits, the surgeon traditionally 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. Significantly 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.

AeroForm allows women to complete their expansion at home, without needles and at their own pace based on their level of comfort.

Company comments

“We are extremely pleased that the AeroForm has received this important regulatory milestone that will give women outside of the United States access to a patient-friendly option for tissue expansion when undergoing breast reconstruction after a mastectomy,” said Scott Dodson, AirXpanders President and Chief Executive Officer. “The company will begin the formalization of its International distribution plan over the next few months while we simultaneously complete our ongoing IDE trial in the United States.”

Source: AirXpanders Inc., Marketwire