Medical device firm AirXpanders has received de novo clearance from the US Food and Drug Administration (FDA) for its AeroForm tissue expander system.
The approval allows the company to market AeroForm as a Class II medical device for breast reconstruction in the US.
AeroForm is said to provide a needle-free alternative for women selecting reconstructive surgery following a mastectomy.
The tissue expander system will be activated by a handheld wireless controller, which administers small amounts of carbon dioxide (CO2) up to three times per day to stretch the tissue to prepare for a breast implant.
The push programmed amount of CO2 is delivered in second with the push of a button from a remote controller, enabling the patient to continue with her daily activities while preparing for reconstruction.
The company also secured CE mark approval for AeroForm to integrate an enhanced inner film liner, which is used to contain the CO2 cannister inside of the device.
This approval allows the firm to market the product in Europe and Australia.
AirXpanders’ president and CEO Scott Dodson said: “The market opportunity for AirXpanders in the U.S. is significant, with the total addressable market worth more than US$800m.
“As U.S. mastectomy rates continue to rise and growing numbers of women undergo breast reconstruction, we are confident AeroForm will positively redefine the reconstruction process for women in the US.”
Image: AeroForm tissue expander system for reconstruction. Photo: courtesy of PRNewsFoto / AirXpanders, Inc.