Aesthetic Arts Institute of Plastic Surgery, US, is enrolling mastectomy patients into a clinical study to investigate a new tissue expansion method for women undergoing breast reconstruction after such procedures.
The randomised controlled clinical study is designed to compare the outcomes of AirXpanders' remote-controlled needle-free carbon dioxide-based tissue expansion system, AeroForm, to a traditional saline tissue expansion method.
The AeroForm tissue expander system features a self-contained tissue expander, which is implanted in the same manner as a traditional saline expander following mastectomy, and a small hand-held wireless remote control unit.
The needle-free technology of an AeroForm expansion system may reduce the discomfort associated with saline expansions and reduce infection rates by eliminating the need for percutaneous filling. In the trial, patients who receive the AeroForm expander will use a wireless remote control to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander.
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, while the secondary objectives will 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 professor Susan Kaweski said the investigational system eliminates the need for saline injections by allowing patients 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.
Earlier feasibility study showed the device demonstrated full expansion in an average of 15 days for patients undergoing breast cancer reconstruction surgery. The company said enrolment of patients will continue until a total of 92 AeroForm devices and 46 saline expanders have been implanted in patients.