Medical device firm AirXpanders reported that its pivotal Xpand trial of AeroForm device has reached the primary endpoint in patients who have undergone a mastectomy.
AeroForm device is an injection-free and patient-controlled tissue expansion system that received approval in Australia and under investigation in the US.
The device is said to use a controlled delivery of small amounts of carbon dioxide (CO2) to achieve the tissue expansion needed for the placement of a permanent breast implant.
Xpand trial principal investigator Dr Jeffrey Ascherman said: "AeroForm has demonstrated that it can be used as effectively as saline expanders in the treatment of women who are going through two-stage reconstructive surgery following a mastectomy."
The Xpand trial is a randomized and controlled trial that enrolled 150 patients across 17 sites in the US.
According to the firm, subjects in the trial achieved successful exchange to a permanent implant with the same safety profile as saline tissue expanders.
The firm will submit the results to the US Food and Drug Administration (FDA), as part of its 510(k) dossier that is planned to be delivered shortly.
The company will present the detailed final trial results of the device at the American Society of Plastic Surgeons Meeting in Boston, Massachusetts, on 18 October.