XPAND II - A Multi-Center, Prospective, Clinical Trial for the AeroForm Tissue Expander System for Two-Stage Breast Reconstruction
Jeffrey A. Ascherman, M.D.1, Kerry A. Morrison, M.D.1, Kamakshi R. Zeidler, M.D.2, James Z. Appel, M.D.3, Khashayar Mohebali, M.D.4, Tracey H. Stokes, M.D.5, Laura Sudarsky, M.D.5, Yoon Chun, M.D.6, John Castle, M.D.7, Amy Colwell, M.D.8.
1Columbia University College of Physicians and Surgeons, New York, NY, USA, 2Aesthetic and Reconstructive Plastic Surgery - Campbell CA, Good Samaritan Hospital, San Jose, CA, USA, 3Novant Health Appel Plastic Surgery, Novant Health Presbyterian Medical Center, Charlotte, NC, USA, 4Mohebali Plastic Surgery, Marin General Hospital, Corte Madera, CA, USA, 5eSSe Plastic Surgery, Broward Health Medical Center, Fort Lauderdale, FL, USA, 6Brigham and Women's Hospital, Faulkner Hospital, Boston, MA, USA, 7University of Massachusetts, UMass Memorial Hospital, Worcester, MA, USA, 8Massachusetts General Hospital, Boston, MA, USA.
BACKGROUND: The XPAND II clinical study interim results are presented confirming the efficacy and safety of the novel, needle-free AeroForm Tissue Expander System when used for two-stage breast reconstruction. The XPAND II multi-center study was conducted as a continued access study under the U.S. FDA IDE regulations. This study is a multi-center, prospective, single arm study designed to confirm the results from the XPAND study, a multi-center, prospective, randomized study for breast reconstruction. The AeroForm device was cleared by the FDA in December 2016 based on the results of the XPAND study and is currently in the early stages of commercialization in the U.S.
METHODS: Fifty (50) women were treated in the XPAND II study and implanted with the AeroForm device (89 expanders). The primary endpoint was successful completion of the second stage surgery. Secondary endpoints were days to complete expansion and reconstruction, and patient/physician satisfaction. Inclusion criteria included age (18-70), BMI (<33) and tissue suitability for expansion. Following implantation, women self-administered 10cc doses of CO2 up to three times daily. When adequate expansion was achieved, the expanders were then exchanged for standard breast implants.
RESULTS: With 48 subjects completed, the interim result by breast (n=85) for the primary endpoint (successful exchange to standard breast implant, precluding non-device related failures) is 100%. All-cause interim success is 95% with three subjects (4 breasts) failing primary exchange due to non-device related reasons (cellulitis with intolerance to antibiotics, seroma with exposure, cellulitis with delayed wound healing). Median time to complete expansion is 20 days (range 5-117). Median time to complete reconstruction is 119 days (range 55-494).
CONCLUSIONS: Results of the XPAND II study provide additional data that the AeroForm patient-controlled, needle-free CO2 tissue expander is safe, efficient, and effective for two-stage breast reconstruction.
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