AirXpanders has reported the positive results of a feasibility study investigating the AeroForm breast tissue expansion device.
The AeroForm system features a self-contained tissue expander and a handheld wireless remote control. It uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander.
The needle-free technology of an AeroForm expansion may reduce the discomfort associated with saline expansions, and reduce infection rates by eliminating the need for percutaneous filling.
The prospective, open-label, single-site and single-arm study involved seven patients who were implanted with ten expanders. It showed that the device demonstrated full expansion in an average of 15 days for patients undergoing breast cancer reconstruction surgery.
Dr Anthony Connell of Mount Hospital in Perth, Western Australia, said that the AeroForm expander has the potential to improve the uncomfortable and lengthy process of expansion for patients and physicians, by eliminating the need for weekly office visits for the needle injections required to inflate a saline filled expander.
”We hope that this technology will help the approximately 75% of women who decide against reconstruction to reconsider their decision," Connell added.
The company expects to enrol up to 138 US patients into the study which will serve as the basis for seeking clearance in the US.