AirXpanders has obtained CE mark approval for its needle-free, patient-controlled tissue expander, designed for patients undergoing breast reconstruction after a mastectomy.
The new technology, AeroForm, incorporates new capabilities without the need to implant a saline tissue expander under the skin and pectoral muscle following the mastectomy.
The study, published in Plastic and Reconstructive Surgery in October 2011, has shown AeroForm’s ability to achieve full expansion in as little as 14 days, while compared to the traditional saline expander which takes up to six months to fill.
AirXpanders president and chief executive officer Scott Dodson said, "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."
The company said it will begin formalizing its International distribution plan over the next few months and complete its ongoing IDE trial in the US.