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Establishment Labs Submits to FDA for Approval of Motiva Implants in Breast Reconstruction
NEW YORK--(BUSINESS WIRE)-- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and
About this update from Establishment Labs Holdings Inc.
[{"type":"text","content":" NEW YORK--(BUSINESS WIRE)--\nEstablishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced that it has submitted Motiva® implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA). The products were previously approved by the FDA for use in breast augmentation on September 27, 2024.\n\n\n“Expanding our FDA approval from breast augmentation to reconstruction is an important step forward for women’s health,” said Jeff Ehrhardt, Senior Vice President and Establishment Labs’ General Manager of North America. “Breast reconstruction has seen little innovation for more than a decade, despite these patients often needing improved and more advanced technology. This milestone brings us closer to offering the benefits of Motiva to women after mastectomy, providing the same proven technology that has seen rapid adoption in breast augmentation.”\n\n\nThe Motiva U.S. IDE Study was conducted at 17 centers in the U.S. and one center in Western Europe and included 274 post-mastectomy reconstruction patients, including 220 primary and 54 revision patients. Motiva® SmoothSilk® Round and Ergonomix® Implants represent state-of-the-art innovation in plastic surgery. These devices feature the patented SmoothSilk® surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation. The Motiva® SmoothSilk Ergonomix® device is the first breast implant in the world that embodies the science of ergonomics, as it is designed to adapt, react, feel, and move like natural breast tissue. Motiva® SmoothSilk® Ergonomix® implants are unique to the implant market, as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. The Motiva® SmoothSilk® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position. Since approval for breast augmentation in 2024, more than 60,000 Motiva implants have been sold in the United States.\n\n\n“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” said Mark Clemens, MD, MBA, FACS, and Professor of Plastic Surgery at The Uni...