In December 2016, the FDA granted regulatory clearance for AirXpander’s AeroForm Tissue Expander System, accelerating the commercial launch of the product in the US. AeroForm has already launched in Europe and Australia, but US-based AirXpander can now dramatically expand sales operations in its own home market and provide patients healing from mastectomies with much needed self-directed recovery options.
Most mastectomy patients undergo months of saline injections to expand tissue before a permanent breast implant can be placed. These techniques require regular office visits to receive painful injections. AeroForm, on the other hand, only requires the one-time implantation of an expander that delivers controlled volumes of carbon dioxide gas to inflate the breast cavity. Another crucial advantage of the AeroForm is its ability to let the patient have control over the course of the treatment. The patient can control the regularity and dosage of the gas expansion via a handheld wireless dosage controller. Furthermore, the device can achieve full tissue expansion in a matter of weeks, rather than months, to make room for a permanent breast implant.
The AeroForm system features single-button activation, indicator lights, and programmed dosing limits for safe and easy use. Putting recovery in the hands of patients healing from debilitating breast cancer treatments not only offers convenience but also provides psychological support crucial for complete recovery.
Breast cancer is one of the more common forms of cancer. Many breast cancer patients, for whom radiation therapy was not sufficient treatment, may elect to undergo mastectomies. Even individuals without breast cancer who have nonetheless tested positive for risk factors may choose to have their breast tissue surgically removed. Therefore, the market for effective breast reconstruction devices remains vast in many countries. AirXpander’s AeroForm has the potential to fulfill both patient and physician expectations in providing an easier road to satisfactory recovery.