Establishment Labs Announces FDA Clearance of Motiva Flora SmoothSilk Tissue Expander
16 October 2023 - 9:00PM
Business Wire
Flora is the only magnet-free and MR
Conditional tissue expander cleared for the U.S. market.
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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version on businesswire.com: https://www.businesswire.com/news/home/20231016421597/en/
Investor/Media Contact: Raj Denhoy 415-828-1044
rdenhoy@establishmentlabs.com
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