Aesthetic Arts Institute of Plastic Surgery is recruiting mastectomy patients to conduct investigational device exemption (IDE) study of AirXpanders' AeroForm patient controlled tissue expander system.
The controlled, randomized study is designed to compare the outcomes of the traditional saline tissue expansion method to the AeroForm system.
AeroForm will be assessed based on its ability to safely expand the tissue to the point that the expander can be replaced with a standard breast implant.
Secondary measurements include the average number of days needed to achieve the desired expansion, total reconstruction time, pain and patient satisfaction.
Aesthetic Arts Institute of Plastic Surgery surgeon Susan Kaweski said the investigational system eliminates the need for saline injections by allowing the patient to trigger the release of small amounts of compressed carbon-dioxide through the valve of a tiny chamber located inside the expander.
"The patient uses the remote control to gradually inflate the investigational expander in small, pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits," Kaweski added.
Aesthetic Arts Institute of Plastic Surgery said enrollment of mastectomy patients will continue until a total of 92 AeroForm expanders and 46 saline expanders have been implanted.