NEW YORK--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, 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.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.
“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,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “Our SmoothSilk® surface 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 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.2
- 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.3
- 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.4
“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,” said Dr. Frank G. Shellock, Director of MRI Safety and Professor of Radiology and Medicine at the University of Southern California. “Furthermore, 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.”
“At our breast center in Madrid, we help thousands of women each year, from annual screenings to treatment of breast cancer and breast reconstruction,” said Dr Antonio Tejerina, Plastic and Reconstructive Surgeon at the Madrid Breast Center in Spain. “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. Including and informing women about the most advanced possibilities in their treatment is the first step in helping them own their recovery.”
- Doloff, J.C., Veiseh, O., de Mezerville, R. et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans. Nat Biomed Eng 5, 1115–1130 (2021). https://doi.org/10.1038/s41551-021-00739-4
- Schoberleitner I, Augustin A, Egle D, Brunner C, Amort B, Zelger B, Brunner A, Wolfram D. Is it all about surface topography? An intraindividual clinical outcome analysis of two different implant surfaces in breast reconstruction. J. Clin. Med. 2023, 12, 1315. doi: 10.3390/jcm12041315
- Schiaffino S, Cozzi A, Pompei B, et al. MRI-Conditional Breast Tissue Expander: First In-Human Multi-Case Assessment of MRI-Related Complications and Image Quality. J. Clin. Med. 2023, 12, 4410. https://doi.org/10.3390/jcm12134410
- Hwang NH, Kim M, Lee NK, Lee S, Hwang J. Dosimetric effect of injection ports in tissue expanders on post-mastectomy volumetric modulated arc therapy (VMAT) planning for left-sided breast cancer. Applied Sciences. 2022, 12 (13), 6461. doi:10.3390/app12136461
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The over three million Motiva® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MR conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patent applications in 25 separate patent families worldwide and over 50 scientific studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants® and began a clinical trial to support regulatory approval in the United States. Please visit our website for additional information at www.establishmentlabs.com.
Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States. The Company’s implants are undergoing PMA clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.
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