The FDA OK’d marketing for the AeroForm (AirXpanders) device, a new wireless tissue expander system for post-mastectomy breast reconstruction patients, according to an FDA announcement late December 2016.
Surgeons can use AeroForm for soft tissue expansion in two-stage breast reconstruction and to treat underdeveloped breasts and soft tissue deformities. The system puts patients in charge, by allowing them to use a dose controller to inflate the expander, a balloon-like device with a soft, expandable polymer shell.
Dr. KluskaMichael S. Kluska, D.O., a cosmetic and plastic surgeon practicing in White Sulfur Springs, W.V. and president of the American Academy of Cosmetic Surgery, tells Cosmetic Surgery Times that he thinks AeroForm is a technologic leap for patients and physicians.
“The patient is more integrated, and one of the most important parts of recovery for a patient, in my mind, is they are accountable, can take part in it and they feel they have control,” Dr. Kluska says.
Using AeroForm also benefits surgeons who take insurance for payment because the patient can do the expanding without having to come into the office, according to Dr. Kluska.
“We get a 90-day global period for placement of that expander. After that, the patient can come in one time or 100 times, and we can’t bill for it,” says Dr. Kluska, who has no conflicts of interest to report.
NEXT: Device Details
Device Details
The tissue expander system has two parts:
- The expander, which is a sterile implant with an outer silicone shell.
- A remote dosage controller, a handheld device that communicates with electronics inside the expander.
Surgeons have to use a needle to expand other types of tissue expanders. The AeroForm is a needle-free device, which is filled with air.
Patients can achieve full expansion in weeks rather than months with traditional, saline-based expanders, and might spend less time in surgeons’ offices because they can expand at home or in the office, according to a company press release.
In a clinical trial of 99 patients using the AeroForm and 52 using a saline expander, researchers reported that 96.1% of patients in the AeroForm group and 98.8% of patients using saline expanders were successfully able to expand breast tissue and go to an implant. No serious events were reported in the AeroForm arm.
Patients who have residual tumors at expansion sites, as well as patients with other electronic implants, such as a pacemaker, are not candidates for the AeroForm system. Those with the device in place should not have magnetic resonance imaging (MRI).
NEXT: Looking long-term
Looking long-term
While the technology is innovative and has generated enough data for FDA to allow the company to market the device, the long-term success of AeroForm remains to be seen, according to William P. Adams, Jr., M.D., program director of the aesthetic surgery fellowship and associate clinical professor at UT Southwestern, Dallas, Texas.
“Once things are FDA approved and placed in the market, the real value is usually sorted out in the first and second years, post approval,” Dr. Adams says. “Furthermore, there is a trend in breast reconstruction to fill expanders to desired volume at the first reconstructive procedure or even direct to implant procedures.”
Dr. Adams says to suggest it takes weekly visits for months for successful expansion without AeroForm is misleading.
“This is typically not the case at all,” Dr. Adams says. “With all of the push toward direct-to-implant reconstruction (in that case there is no expander), and in the current expander procedures, the expanders tend to be filled 50 to 100%, so there is often only one to two more visits to fill it to the desired volume.”
