AirXpanders has treated the first mastectomy patient undergoing breast reconstruction in the AirXpanders patient activated controlled tissue expander system for breast reconstruction (XPAND) trial, using its AeroForm breast tissue expansion device.
The AeroForm tissue expander system features a self-contained tissue expander and a small hand-held wireless remote control.
The prospective randomised controlled open-label pivotal XPAND study will compare the outcomes of tissue expansion of the traditional saline expansion method to the investigational AeroForm, remote-controlled, needle-free tissue expander.
An earlier feasibility trial in Australia showed that the average expansion time associated with the AeroForm remote-controlled tissue expander was 15 days, a fraction of the time required using traditional saline expanders.
Principal investigator of the XPAND trial Leroy Young said the earlier PACE feasibility trial reported that the AeroForm device had the ability to provide breast cancer patients a needle-free and convenient tissue expansion process as part of breast reconstruction following a mastectomy.
"This study will compare the patient-controlled, carbon-dioxide-based AeroForm device with the standard saline injection method, an often arduous process that has historically been a major deciding factor against breast reconstruction for many women," Young added.
The company said enrolment of patients would continue until a total of 92 AeroForm devices and 46 saline expanders have been implanted in patients.