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Methods: Female patients who signed informed consent were 18-70 years old, not current smokers, had BMIs < 30 and were enrolled in this prospective, open-label, single-arm, feasibility trial of the investigational device (the AeroForm System). Subjects underwent latissimus dorsi pedicled flap procedures (per standard practice of the investigator) for additional muscle coverage. Post-implant, subjects were followed until adequate wound healing. They were then instructed to use the remote dosage controller to administer 10-cc doses of CO2 up to three times daily based on their comfort level. After 6–8 weeks post full expansion, subjects underwent explantation of the tissue expander and placement of a permanent implant. Descriptive statistics were used.

Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation