AeroForm Tissue Expander System for Breast Reconstruction Cleared by FDA

The AeroForm Tissue Expander System from AirXpanders, a company based in Palo Alto, California, won FDA de novo regulatory approval to be introduced for sale in the U.S. The device is designed to provide a better option over saline expanders for women undergoing breast reconstruction following a mastectomy.

Currently, saline expanders are implanted that are then inflated via regular injections of saline. This requires office visits and involves some pain during what could take months to complete.

The AeroForm implant includes a CO2 capsule that can be activated using a remote control to release the gas into the main chamber of the device. This allows it to be expanded when the patient is ready, be it at home or at work, and the pressure carefully controlled not to cause too much pain. Office visits to do needle injections are not necessary and the company claims its approach leads to successful expansion in weeks as opposed to months.

The company has also announced that in Europe it received regulatory approval to integrate an improved inner film liner into the chamber within which the CO2 canister resides.

Here’s a company video discussing the AeroForm Tissue Expander System:

Flashbacks: AirXpanders AeroForm Tissue Expander for Breast Reconstruction CE Marked…; Tissue Expansion System for Breast Reconstruction Receives FDA Investigational Device Exemption…; AeroForm Breast Tissue Expanders Now Being Implanted in IDE Trial…

Product page: AeroForm…

Via: AirXpanders…