Establishment Labs: FDA Clears Motiva Flora SmoothSilk Tissue Expander - Quick Facts

(RTTNews) - Establishment Labs Holdings Inc. (ESTA), a global medical technology company which offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction, announced the FDA has granted 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander. The Flora SmoothSilk Tissue Expander comes with Establishment Labs' patented SmoothSilk surface technology. SmoothSilk has been shown to produce the least amount of inflammation and foreign body response compared to other implant surfaces. Flora also includes an RFID-enabled, non-magnetic port, labeled as MR Conditional by the FDA.

The Motiva Flora Tissue Expander has been available in Europe and other global markets since 2021. The company said its SmoothSilk surface will now be available to women in the United States.

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