Compared to saline injections, the breast augmentation device developed by AirXpanders has been advertised as less painful and is another option for patients undergoing mastectomy.
It all started with the tire leaking. At that time, plastic surgeon Daniel Jacobs of San Jose, Calif., took out a carbon dioxide compressed gas cylinder to inflate the bicycle tires, and then began to think about whether he could use the same technology on the breast tissue spreader.
Eleven years later, a company inspired by the idea has completed a critical trial and is awaiting approval from the US Food and Drug Administration (FDA) 510(k). Aeroform, a needle-free injection device with a wireless tissue expander system, was developed specifically for patients undergoing reconstructive surgery after mastectomy, and AirXpanders is looking for opportunities to market the breast augmentation device on the market.
After mastectomy, the Aeroform tissue dilator is placed under the chest muscles, stretching the chest wall to make room for permanent breast implants. The unit contains a carbon dioxide compressed gas tank. Using a hand-held wireless remote control, the patient can release 10 cc of carbon dioxide gas each time to gradually expand the expander up to three times a day. According to AirXpanders, the entire operation takes only a few seconds, whether at home or at work.
The traditional saline-based tissue expansion method requires patients to seek medical treatment many times, and the process is painful. The amount of saline injection per time can be up to 60 cc. This can make the skin and muscles expand a lot, so the whole process can be painful. Dr. Jeffrey Ascherman, chief experimental researcher and MD, from the Department of Medical Surgery at Columbia University, explained in an interview. In contrast, the AeroForm breast augmentation device is another alternative, allowing only 10 cc of carbon dioxide gas to be released at a time, with less skin stretching and less damage, he added. If a woman wants to omit one or two doses, or even a full day dose, she can do the same.
XPAND, a key trial of the device, included 150 patients in 17 locations in the United States and recently reached its primary endpoint. The trial showed that the average expansion expansion time of the Aeroform group was 21 days, and the average expansion time of the saline treatment group was 46 days. The results of the randomized controlled trial are scheduled to be published in the Journal of Plastic Surgery on November 28.
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