If you’ve just started lurking around Xpanding the Story (please do), you might not yet have figured out who we are and what we are. We thought we would give you an answer to that question this week.
First off, we’re a blog for a medical device company named AirXpanders®, and our product is called AeroForm®. We’re beyond proud of this particular device and believe it has the potential to transform the breast reconstruction process.
What’s so exciting about AeroForm®?
To sum it up, AeroForm® is a needle-free, wireless tissue expander system.
Traditionally, most breast cancer survivors who choose implants for their breast reconstruction require the insertion of a tissue expander first. These expanders might be placed at the time of the mastectomy or a later date, but they are deflated balloon-like devices, which, as they are filled, slowly make room in the chest wall for the eventual permanent implants. Unfortunately, the traditional form can be quite the ordeal for both the woman and her physician. The expanders must be expanded in the surgeon’s office with saline solution injections over a period of three to six months. Women often report this process as quite painful, in addition to feeling frustrated over the time it takes away from their daily routine, just when recovering cancer patients are ready to move on with their lives.
AeroForm® is quite different. (Did I mention that we’re proud of this device?)
As with the traditional saline expanders, the AeroForm® is placed behind the chest wall during an initial surgery. At the time of the surgery, a small amount of compressed CO2 will be placed in the device. The woman then goes home and allows her scars to heal. When she and the doctor feel she is ready, she uses a wireless dose controller (it looks a bit like a remote control) to begin expansion at home. Or at work. Or on vacation.
Frankly, we believe in empowering women, especially women who’ve had so many choices robbed from them by breast cancer. That’s why expansion is placed in the woman’s hands. She has the control to release 10cc of CO2, up to 3x per day. The choice is hers: some days she might release only once and other days all three allowed times depending on how she’s feeling. As a protective measure, the device provides the woman a 3-hour lockout between doses, so that she cannot fill too quickly.
At home. At her convenience. No more visits to the surgeon to fill expanders.
And the results?
It doesn’t take three to six months, as in the case of saline expanders. Actually, the results from U.S. and Australian clinical studies of AeroForm® have demonstrated a significant reduction in the time to full expansion, with an average of only 17 days!
Moreover, AeroForm® has completed its FDA-approved pivotal trial in the US, and we are working with the FDA to seek further approval. Meanwhile in Australia, following three open-labeled clinical studies, the Australian TGA (Therapeutic Goods Administration) has approved the device, where it is now already being sold.
We’re really excited to see this transformative device spreading! As I said, we’re proud of it, and we’ll absolutely keep you updated as we seek FDA approval. However, we’ll also keep you updated on other exciting developments in the world of breast reconstruction, because at the end of the day, the reason we’re so excited about our device, is because we believe in improving all women and physicians’ experiences of breast reconstruction.