The AeroForm tissue expander, manufactured by AirXpanders, headquartered in Palo Alto, Calif, can now be marketed, according to a media release from the US Food and Drug Administration.

The AeroForm device for soft tissue expansion is used in women undergoing two-stage breast reconstruction following mastectomy, as well as in the treatment of underdeveloped breasts and soft tissue deformities.

The wireless AeroForm tissue expander fills with air rather than saline, does not need a needle, and enables patients to slowly expand the device at home rather than at a doctor’s office.

“This tissue expander may result in fewer office visits for patients by allowing a patient to partially control their breast tissue expansion,” said Binita Ashar, MD, director of the Division of Surgical Devices at the FDA’s Center for Devices and Radiological Health, in the FDA release.

“Patients need to speak with their surgeons about what type of tissue expander is appropriate for them and the benefits and risks of using an expander following their mastectomy,” Ashar adds.

As part of the approval process, the FDA reviewed results from a clinical trial of 99 patients using the AeroForm expander and 52 patients using the saline expander. The results showed that 96.1% of patients using AeroForm expanders and 98.8% of patients using saline expanders were able to have their breast tissue successfully expanded and exchanged to a breast implant, the release explains.

A surgeon must determine whether the patient is a suitable candidate for treatment with the device. Patients must not have any residual tumor at the expansion site and must not undergo magnetic resonance imaging (MRI) while the device is in place. Patients with another electronic implant (eg, pacemaker, defibrillator, or neurostimulator device) are not eligible for treatment with the AeroForm tissue expander, the release continues.

[Source: US Food and Drug Administration]