Tissue Expansion System for Breast Reconstruction Receives FDA Investigational Device Exemption

Though mastectomies are often a necessary and even welcome intervention to save the lives of women suffering from breast cancer, they also may contribute to the overall physical and emotional trauma facing the patients. In order to alleviate some of these problems, surgeons have developed breast reconstruction procedures that usually entail restoring the mound by implanting a silicone sac filled with salt solution (saline) or gel under the skin and pectoral muscles. The traditional process to prepare for implantation of the sac may be long and sometimes painful because it involves weekly bolus saline injections (sometimes up to 22 weeks) in order to create a pocket of sufficient size.

A potential alternative solution is being developed by AirXpanders, a med tech start-up in Palo Alto that focuses on tissue expansion for breast reconstruction following cancer. Their system, known as AeroForm, just recently received an Investigational Device Exemption from the FDA so that its efficacy may be tested in a randomized, controlled, open-label study. In terms of how the system works, according to the press release:

AirXpanders designed the AeroForm tissue expander to address the limitations of traditional saline expanders. The system consists of a technologically advanced self-contained tissue expander and a small hand-held wireless remote control. The AeroForm system uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander. Following a standard procedure to implant the expander, the patient can use the remote control at home to perform the expansion process as directed by the surgeon.

During the company’s feasibility trial in Australia, the average expansion time associated with the AeroForm remote-controlled tissue expander was 15 days, a fraction of the time typically required using traditional saline expanders.

We look forward to learning how the study, known as XPAND, progresses and will be sure to keep you up-to-date!

Product page: AirXpanders …

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