For 40 years, plastic surgeons have used saline injections to expand tissue and prepare patients for breast implants following mastectomies. These tissue expanders consist of a silicone shell with a magnet and a self-sealing port; a doctor uses a different magnet above the skin to access the port and inject saline to stretch the skin. The process is lengthy – patients come into the doctor’s office every week for as much as 3 months.
Dr. Tracey Stokes, a plastic surgeon based in Fort Lauderdale, Fla., has spent 11 years working with mastectomy patients, often using saline expanders to prepare them for breast implants. Not surprisingly, Stokes told MassDevice.com, many patients are daunted by the prospect of such a lengthy and painful series of procedures.
So about 2 years ago, she agreed to be the principal investigator in a pair of clinical trials of the AeroForm device made by AirXpanders (ASX:AXP), an needle-less alternative to the conventional saline tissue expander.
The AeroForm system is an implanted device that uses gradual increases of pressurized carbon dioxide to expand the patient’s breast tissue to accommodate the new implant. After a mastectomy – often even during the same procedure – a plastic surgeon places the AeroForm expander under the skin and chest muscle. To begin the expansion process, patients pass a controller over the top portion of their chest to detect the device. When that happens, the controller signals the patient to administer a small amount of carbon dioxide.
In a 150-patient U.S. study published in Plastic & Reconstructive Surgery, comparing the AeroForm device and traditional saline expanders, the AeroForm group completed tissue expansion in 21 days, compared to 46 days for the control group. The AeroForm cohort also completed full reconstruction a month sooner than their counterparts in the control arm.
That’s not all that patients find attractive about the device, Stokes told us.
“What has been revolutionary about the AeroForm, and what patients have liked the most about the AeroForm, is that they are in control at a time when they’ve lost control in their lives,” she said, noting that patients can choose to administer up to 3 doses a day, with an upper limit of 210 ccs a week. In contrast, saline injections are done 50 ccs at a time, Stokes explained.
Palo Alto, Calif.-based AirXpanders won FDA de novo clearance for AeroForm last month and said that it will focus the product’s release on high-volume academic and community hospitals that participated in the device’s clinical trials. The company won CE Mark approval in the European Union in 2012, although it does not sell its device in the European market. AirXpanders has been selling AeroForm in Australia since 2014 and reported mid-year revenue of $216,644 in August last year. To date, AeroForm has been evaluated in 5 clinical trials and 13 peer-reviewed publications, the company said.
Stokes told us that she’s excited to work with a device that is helping her patients regain some power in their lives at a time when they feel out of control.
“I feel like half the time I’m a psychiatrist with a scalpel,” she said.”It’s about listening to people’s needs and understanding exactly what they want and achieving those goals in as safe a way as possible.”