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Human Factors Validation of the AeroForm Tissue Expander System for Breast Reconstruction
1Kathy Kelley, RN, BSN, is Senior Director of Clinical Affairs at AirXpanders and has more than 20 years of experience in hospital clinical, quality, and risk management, including more than 10 years of experience in medical device clinical research and medical quality analysis. Kathy received her Bachelor of Science in Nursing from Boston University. Jennie Kim, MHS, is Senior Director of Global Marketing at AirXpanders and has more than 15 years of experience in healthcare marketing and public relations including extensive experience in medical device marketing targeting healthcare professionals and consumers. Jennie received her Masters of Health Sciences degree from the Johns Hopkins University School of Public Health and her Bachelor of Arts degree from Pomona College.
Abstract:
The tissue expansion process using traditional saline expanders is lengthy and uncomfortable. A new technology has been developed, providing a needle-free option implanted after a mastectomy, and is activated by a handheld remote control releasing small amounts (10 cc) of carbon dioxide from an internal reservoir. The expander is gradually filled with CO2 resulting in mechanical stretching of the overlying tissue. The AeroForm System has been evaluated in a series of clinical trials including a randomized, controlled U.S. study comparing the AeroForm System with saline expanders. Results demonstrated patients can safely and reliably dose and complete their expansions in half the time compared to saline expanders. A human factors validation study was conducted in 8 patients to evaluate whether patients could correctly use the device to complete their expansion at home. The sessions were recorded and data on performance, behavioral, and subjective measures were collected and analyzed and submitted to the FDA as part of the U.S. marketing approval. All 8 participants were successful in using the controller to deliver a simulated dose. Participants found the device easy to use and the training material provided adequate to understand use of the controller. For women who choose 2-stage breast reconstruction, a new safe and effective option is available for tissue expansion, offering a convenient and empowering alternative. The human factors validation study conducted confirmed the simplicity of the device and further validated that the device can be used safely and effectively for breast tissue expansion.
