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 Motiva Flora® SmoothSilk® Tissue Expander was used for the first time in the United States at the University of Texas MD Anderson Cancer Center in Houston by Mark Clemens, MD MBA FACS, Professor of Plastic Surgery. The recent FDA clearance and first procedure mark significant developments in the field of plastic and reconstructive surgery.
“This Flora device is a new resource in our toolkit for breast cancer reconstruction,” Dr. Clemens noted. “It introduces features such as being MR conditional and also reduces interference during radiation therapy. It’s essential for patients to have access to innovative solutions that may improve their treatment outcomes and facilitate their journey of restoration.”
The Flora® Tissue Expander includes several proprietary innovations, including Establishment Labs’ patented SmoothSilk® surface technology and an RFID-enabled, non-magnetic port, labeled as MR Conditional by the FDA. SmoothSilk® has been shown to produce the least amount of inflammation and foreign body response compared to other device surfaces1. By being magnet-free, Flora avoids the interference that magnets cause during MRI and may improve the precision of radiation oncology treatment. All other commercially available breast tissue expanders include magnets.
“We are so pleased to enter the United States, the largest market in the world for breast reconstruction,” added Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “Our company is grounded in the core principle of improving women’s health and wellness, and the U.S. deserves the highest standard of care. Real innovation leads to better patient outcomes, and Flora is setting a new standard in breast reconstruction.”
