Establishment Labs Announces FDA Clearance of Motiva Flora SmoothSilk Tissue Expander
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Monday, October 16, 2023
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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.
Key Points:
- 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.
- By being magnet-free, Flora avoids the interference that magnets can cause during MRI and may improve the precision of radiation oncology treatment.
- “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.