Establishment Labs Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) 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. 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. The Motiva Flora Tissue Expander has been available in Europe and other global markets since 2021 and has been studied in several independent scientific publications. Among the notable findings: 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. In the first in-human multi-center study of patients undergoing 3-Tesla MRI, Flora did not affect the image quality of the most important part of the breast MRI protocol and there were no MRI-related complications or MRI-related damage to the expander port.

In a radiotherapy planning study comparing the dosimetric effect of traditional metallic ports to the RFID port in Flora, Flora showed better dosimetric results to the heart and lungs vs traditional metallic ports, potentially reducing side effects to these organs. The RFID port materials also reduced artifacts on CT imaging compared to the metals used in conventional expanders.