Establishment Labs Holdings Inc. announces the first-ever utilization of the Motiva Flora SmoothSilk Tissue Expander in the United States, following its recent FDA clearance. Mark Clemens, MD, MBA, FACS, a plastic surgery professor at the University of Texas MD Anderson Cancer Center, performing the inaugural procedure.
“This Flora device is a new resource in our toolkit for breast cancer reconstruction,” Clemens says. “It introduces features such as being MR-conditional and 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 technologies, including Establishment Labs’ patented SmoothSilk surface technology and an RFID-enabled, non-magnetic port, labeled as MR-conditional by the U.S. FDA. SmoothSilk has been shown to produce the least amount of inflammation and foreign body response compared to other device surfaces. 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,” says Juan José Chacón-Quirós, founder and CEO 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.”