Establishment Labs Holdings Inc. announces that it has obtained U.S. FDA 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander, which features patented SmoothSilk surface technology to reduce inflammation and an MRI-compatible port without magnets for improved MRI scan accuracy and radiation oncology treatment precision. which features patented SmoothSilk surface technology to reduce inflammation and an MRI-compatible port without magnets for improved MRI scan accuracy and radiation oncology treatment precision.
“This is an incredibly important day in the history of Establishment Labs, as the first of our implantable technologies has been approved by the FDA,” says Juan José Chacón-Quirós, founder and CEO of Establishment Labs. “Our SmoothSilksurface will now be available to women in the United States, and this technology is transformative for our industry and patient outcomes. Tissue expanders have seen little innovation for more than a generation, and, in partnership with breast cancer centers, Establishment Labs is creating a new standard of care in breast reconstruction.”
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 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 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. Moreover, 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.
Frank G. Shellock, PhD, FACR, FISMRM, director of MRI safety and professor of radiology and medicine at the University of Southern California, spoke out about the FDA clearance, commenting: “The technology used by the Flora SmoothSilk Tissue Expander that enabled it to be labeled MR-conditional will have a critical impact on patients during their breast reconstruction journey, permitting them to undergo MRI, the most important diagnostic imaging modality.”
Plus, he says, “women working in the MRI environment now have a safe option that will allow them to work in and around an MRI system during their breast tissue expansion process.”
Antonio Tejerina, MD, a plastic and reconstructive surgeon at the Madrid Breast Center in Spain, says he’s seen the benefits of the expander firsthand. “After using this tissue expander in more than 180 cases over the past two years, I can confidently state that Motiva Flora is a new standard of care and the best tool to achieve an aesthetic breast reconstruction,” Tejerina says. “Including and informing women about the most advanced possibilities in their treatment is the first step in helping them own their recovery.”