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Establishment Labs’ Motiva Flora Tissue Expander Receives CE Mark
NEW YORK, June 11, 2020 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially
About this update from Establishment Labs Holdings Inc.
[{"type":"text","content":"NEW YORK, June 11, 2020 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced it has received CE Mark for the Motiva Flora Tissue Expander.\n “Unlike traditional tissue expanders with magnetic ports, a patient with a Motiva Flora Tissue Expander can be safely scanned immediately after placement using MR systems operating at 1.5- or 3-Tesla,” said Frank G. Shellock, Ph.D., Adjunct Clinical Professor of Radiology and Medicine, and Director of MRI Safety, University of Southern California, and author of the widely used Reference Manual for Magnetic Resonance Safety, Implants, and Devices. “I am extremely gratified to finally see technology that can enhance the standard of care for patients undergoing tissue expansion for breast reconstruction that may need an MRI exam for health reasons.” “We are pleased that oncologists, plastic surgeons and patients will now have access to advanced, patented and patent pending technology that offers substantial improvements over existing tissue expander products,” said Juan José Chacón Quirós, Chief Executive Officer of Establishment Labs. ” Motiva Flora is another example of our unwavering commitment to women’s health as we continue to transform the breast aesthetics and reconstruction industry through science and innovation.” The Motiva Flora Tissue Expander, with its proprietary SmoothSilk surface, is the only such product with an integrated RFID port with no magnets, allowing for use of the expander safely alongside MRI scanning. Recently published research1 concluded that Flora offers potential advantages for patients undergoing MRI compared with tissue expanders that have magnetic ports that create substantial signal losses and distortion on MR images. Motiva Flora and Motiva Implants offer the SmoothSilk surface, a bioengineered nanosurface that has demonstrated a very low rate of capsular contracture and no reported cases of BIA-ALCL to date. Already a leader in the European breast enhancement market with its portfolio of Motiva branded products, Establishment Labs intends to extend its presence into the reconstruction market with the introduction of its Flora tissue expander alongside Motiva Implants. The Company expects to immediately comme...