AirXpanders has completed enrollment of 150 subjects in a multicenter study of the company's AeroForm patient-controlled tissue expander.
The study, titled AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction (XPAND), is designed to compare outcomes in two-stage breast reconstruction with AeroForm versus traditional saline expanders. The traditional method requires women to visit their physician for frequent injections of saline until they complete the process, which can take up to six months, the company said.
In contrast, women who receive AeroForm expanders in the study use a wireless remote control to trigger the release of small amounts of carbon dioxide to fill the tissue expander. Once the tissue is adequately expanded, the women return to have their expanders removed and a standard breast implant placed.
At the completion of study enrollment, 98 women were implanted with AeroForm expanders and 52 women with saline expanders. More than 70% of women in the trial had bilateral procedures, according to AirXpanders.
The company said it intends to complete its 510(k) submission to the U.S. Food and Drug Administration (FDA) soon.
