The randomized, controlled clinical study is designed to directly compare the outcomes of a remote-controlled, needle-free, tissue expansion system known as the AeroForm Patient Controlled Tissue Expander System to the traditional saline tissue expansion method.

As part of the tissue expansion process, the skin and tissue are stretched at the site of a mastectomy so that a standard saline or silicone breast implant can be placed.

The study will select patients randomly who will receive the investigational expander and use a wireless remote control to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander, according to a protocol directed by Dr. Ankit Desai and Dr. Michael Fallucco.

The expander from the patient will be removed and placed with a standard implant, after her tissue is adequately expanded.

The study, which sees the participation of Baptist South Medical Center and other hospitals across the US, will continue enrollment until a total of 92 AeroForm expanders and 46 saline expanders have been implanted in patients.

AeroForm will be evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a standard breast implant.

California-based medical device company AirXpanders designed the AeroForm Patient Controlled Tissue Expander.