FDA Approves Novel AeroForm Tissue Expander system for breast reconstruction.

AeroForm Systems.

The AeroForm Tissue Expander systems by AirXpanders, a US based medical device company based at Palo Alto, California, won FDA approval to be introduced in US Markets.[1] AeroForm is currently available in Australia, where it was approved for sale in late 2014.[2]

It can also be used for patients with underdeveloped breasts and soft tissue deformities or scarring.

AeroForm has two main components: the “expander’ is a sterile implant with an outer silicone shell and a remote dosage “controller”. The expander houses a gas reservoir that is released gradually to inflate the expander by the controller.

http://www.airxpanders.com/aeroform-technology/

Surgeons are using saline expanders since last 40 years to expand the soft tissue and prepare patients for breast implants following mastectomies. Currently, saline expanders are implanted by surgeons and requires regular office visits for injections of saline. The AeroForm system is placed behind the chest and uses a gradual patient-controlled release of compressed carbon dioxide to expand the tissue in preparation for breast implant.

The patient controls the doses of carbon dioxide by a hand held remote control device. AeroForm doses are small 10cc puff each that gets the patient expanded in 17 days’ vs 3 months taken by saline expanders.

Data from the XPAND pivotal clinical study on the use of the system was presented at the American Society of Plastic Surgeons (ASPS) Plastic Surgery: The Meeting 2016 in Los Angeles.  In the study 99 patients used AeroForm while 52 patients used saline expander.  A significant reduction in time to expansion, with increased patient satisfaction and safety was achieved by AeroForm.

A company video discussing the AeroForm Tissue Expander System:

Jeffrey Ascherman, MD, chief of the division of plastic surgery at Columbia University and principal investigator for AirXpanders' U.S. XPAND trial said "As surgeons, we have long understood the burden that tissue expansion places on women during breast reconstruction. As greater numbers of women have mastectomies, there is a real need to make the process shorter and more comfortable for women.”

He further added “Reconstruction is one of the last phases of a long and sometimes taxing journey for women who are treated for breast cancer. They have lost time and control, and are eager to get back to their lives. Needle-free, patient-guided expansion could be a suitable option for many women undergoing the reconstruction process."

The adverse effects seen with the device are necrosis, seroma, procedural pain and wound infection.

FDA notes in its news release “Patients must not have any residual tumor at the expansion site and must not undergo magnetic resonance imaging (MRI) while the device is in place. Patients with another electronic implant (e.g. pacemaker, defibrillator, or neurostimulator device) are not eligible for treatment with the AeroForm tissue expander."

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[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534192.htm

[2] http://www.airxpanders.com/aeroform-vs-saline/