Establishment Labs receives FDA clearance for Motiva Flora Tissue Expander

Establishment Labs Holdings announced that the FDA has granted 510k clearance for the Motiva Flora SmoothSilk Tissue Expander. The Flora SmoothSilk Tissue Expander offers several proprietary innovations, including 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.1 Flora also includes an RFID-enabled, non-magnetic port, labeled as MR Conditional by the FDA. By being magnet-free, Flora avoids the interference that magnets can cause during MRI and may improve the precision of radiation oncology treatment. All other commercially available breast tissue expanders include magnets. In a blinded head-to-head study where patients were randomized to receive Flora in one breast and a U.S. commercially available tissue expander in the other, patients reported significantly higher aesthetic and comfort scores, as well as less breast pain, discomfort, and nipple sensitivity with Flora. Surgeons reported higher satisfaction with lower pole expansion as well as with the footprint created by Flora. The capsule tissue around the Flora expander was thinner and the peri-prosthetic fluid was significantly lower than with the comparative device.