Home » FDA Permits de novo Clearance for AirXpander’s Tissue Expander System
FDA Permits de novo Clearance for AirXpander’s Tissue Expander System
AirXpanders has received FDA de novo clearance for the AeroForm tissue expander system, a Class II medical device used for breast reconstruction.
AeroForm is activated by a handheld wireless controller that administers small amounts of carbon dioxide to gradually stretch the tissue to prepare for a breast implant.
Aerform is a minimally-invasive device designed for patients who chose reconstructive surgery after a mastectomy.
AeroForm launches January 2017 in the U.S. — Cynthia Jessup
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