The FDA has granted de novo clearance to the AeroForm tissue expander system, putting it on a path to commercial launch in the U.S.
Developed and manufactured by AirXpanders, headquartered in Palo Alto, California, the Aeroform is designed to assist patients who’ve undergone mastectomy prepare for two-stage breast reconstruction surgery.
Using the AeroForm system, a surgeon implants a tissue expander that is equipped with a reservoir of carbon dioxide (CO2). The patient then uses a handheld wireless controller to administer small bursts of CO2 in the expander. Eventually, the muscle, breast tissue, and skin is stretched the necessary amount to accommodate a permanent breast implant.
The current norm for that preparatory work entails regular physician visits to receive saline injections to manipulate a tissue expander that’s been implanted under the chest muscle.
“Not only is the filling of the current saline devices not a pleasant experience for patients, it can also be very challenging for surgeons,” says Scott Dodson, CEO of AirXpanders. “No one likes to administer pain to patients. So the reality with this device is that the patient takes the dose controller home. Now she can dose up to three time a day with a three hour lockout between doses and needs fewer visits back to the surgeon’s office.”
In the clinical trials AirXpanders conducted, they found patients were diligent about administering the doses. The patient empowerment that comes from actively participating in their own care also provided a somewhat unexpected psychological benefit.
Putting more control in the hands of patients also results in a cleared schedule for physicians.
“That’s beneficial to the surgeon because they are reimbursed one upfront global fee, so they get no incremental reimbursement when these patients come back to their office,” explains Dodson. “With that time that they’re saving from not seeing these patients as frequently, they can see more patients in their clinic or put in more time in the operating room time.”
AirXpanders anticipates an official U.S. commercial launch for the AeroForm later this year.