Necessity may be the mother of invention, but using existing technology in new ways might be its sister. (Did that metaphor hold up?)
It's always interesting to hear about a medical device with an unusual provenance. Today's Med Device Monday pick came about when inspiration struck a plastic surgeon who watched a tire fill with air.
Breast cancer reconstruction surgery rebuilds and reforms the breast after mastectomies and other breast cancer surgeries, and it typically requires expanding breast tissue. Until now, this expansion process has used saline injections. AeroForm, a device reviewed via the de novo pathway, instead uses air. The benefits are numerous. Rather than weekly visits to the doctor to get injections of saline into the breast device (a sterile silicone implant inserted into the breast to be filled), the process is done at home and controlled by the patient–all at the touch of a button.
The patient exercises full control over the expansion and fills the pocket in the breast at a rate that is comfortable for them. There are also no needles involved (we've talked about the benefits of needle-free procedures here before). Additionally, not using saline means a subsequent lack of risk that saline will leak into the surrounding tissue. While such leaks are most often harmless, they do increase the risk of infection among other potential complications. Check out FDA's pamphlet on ruptured saline implants and this study about fungal growth in breast implants for more information.
AeroForm's concept, much like its inspiration, is simple. A carbon dioxide cartridge in a 'pocket' in the breast discharges 10 cc of air at a time (saline injections can be up to 60 cc). The patient has a controller which they hold over the breast and simply click to trigger the cartridge to release the carbon dioxide into the pocket. Smart, simple, and less invasive. Furthermore, involving patients in their own healthcare is a good thing. Per this study of patient involvement, "patient participation causes improved health outcomes, enhanced quality of life, and delivery of more appropriate and cost effective services".
Check out one patient's experience with a trial:
FDA has permitted AirXpanders, the maker of AeroForm, to begin marketing the device. The FDA news release in December stated that the device is now allowed to be marketed in the US, but as of publishing this information, the Classification Order and Decision Summary are not available on FDA's website.