The device could represent the first major change in expansion procedures in 40 years.

Nancy Crotti

FDA has granted de novo clearance to the first breast-tissue expander that uses air instead of saline and shortens the process from mastectomy to reconstruction.

AirXpanders of Palo Alto, CA, recently completed the second phase of its XPAND clinical trial for the AeroForm device. Placed underneath the chest muscle, the needle-free device contains a reservoir of compressed carbon dioxide. Using a hand-held, wireless dose controller, the patient can release 10cc of CO2 up to three times per day to gradually inflate the expander. This can be done from home or work, and only takes a few seconds, according to the company.

It's an alternative to the traditional method of saline-based tissue expansion, which requires multiple medical office visits and saline injections of up to 60 cc. The trials showed that time to expansion averaged 21 days for the AeroForm group versus 46 days for saline group.

Principal trial investigator Jeffrey Ascherman, MD, of the Columbia University Department of Surgery, told MIT Technology Review that the device could represent the first major change in breast tissue expansion in 40 years.

AeroForm gives patients a feeling of control over their treatment, according to Kamakshi Zeidler, MD, a plastic surgeon at Good Samaritan Hospital in San Jose. Zeidler took part in both trials, which included a total of 200 patients at multiple U.S. sites, and recently performed the first commercial implant.

One double-mastectomy patient casually did an expansion while dressing following an office visit, almost without a break in the conversation, Zeidler said in an interview. It was quite a contrast to multiple-step, saline expansion procedures.

"To have that whole experience changed to something that just becomes part of the routine, it's unbelievable," Zeidler said. "That feeling is what I felt patients have really latched onto. There's something really exciting about this technology. It really changes the experience for a patient."

AirXpanders modified a few aspects of the device during the trials, getting the antenna to communicate properly, improving patient comfort, and making the valve easier to open and more reliable, Zeidler reported.

"It still blows my mind that somebody designed a device that actually works," she added. "This technology is very sophisticated."

AirXpanders has sold 600 units in Australia, where AeroForm has been available since 2014, according to the company. The device received CE Mark in Europe in 2012, but the startup has chosen to launch in the United States first.

Trial participants have suggested that the company consider a smartphone app that could connect patients to one another or send expansion data to their physicians, Zeidler said. Such an app could really help Australian patients, some of whom must travel long distances to visit their doctors, she said.

AirXpanders is targeting the high-volume academic and community hospitals that participated in the trials for its initial sales. Zeidler believes that access to AeroForm might persuade more patients to consider breast reconstruction, especially those in rural areas.

"I'm very happy with what they've achieved in the current product that's being offered," she said. "I'm excited about future plans."

Nancy Crotti is a freelance contributor to Qmed.

[Image courtesy of AIRXPANDERS]