A new wireless system could enhance the comfort and convenience of tissue expander breast reconstruction.
Until recently, tissue expansion, a procedure that enables the body to grow extra skin in breast reconstruction, was limited to injections, which involved time-consuming office visits. A silicone balloon expander was inserted under the skin near the area to be repaired, then gradually filled with salt water over a period of 4-6 months, causing the skin to stretch and preparing the breast for a permanent implant.
The new AeroForm patient-controlled tissue expander (PCE) allows for wireless control of tissue expansion through carbon dioxide inflation. “[It] has a needle-free design and anatomical shape, is lightweight, is expanded at home by the patient, is dosed according to comfort….and is easy to use,” observes Tony Connell, MD, principal investigator of the Patient Activated Controlled Expansion (PACE) II trial.
After being implanted, the small and anatomically shaped expander device is activated the first few times by the surgeon during the early healing phase. Then the patient takes over the job, using a remote-control device to send signals to the expander to release small amounts of compressed carbon dioxide.
Manufactured by AirXpanders, Inc. of Palo Alto, California, the AeroForm has been through successful clinical trials in Australia, with results confirmed in a larger trial in the United States. Not only were expansion and reconstruction achieved nearly every patient, but both the women and their physicians expressed 100 percent satisfaction with the device.
In the US trial, the average expansion time was 17 days with the PCE vs. 52 days with the saline expander, while the time to final implant was 106 days vs. 150 days with the saline device.
Last October, AirXpanders received the European CE mark of approval, which enables the company to commercialize the system in Europe and other select markets around the world. Additional confirming trials are still underway in the US.