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Establishment Labs Announces CE Mark Approval for Minimally Invasive Surgical Tools
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 it has received CE marking under the European Medical Device Regulation for the Motiva Injector®, the Motiva® Inflatable Balloon, and the Motiva® Channel Dissector.\n\n\n“The approval in Europe of our minimally invasive tools is an important step in the evolution of plastic surgery,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer. “Innovations that improve both the experience and outcome of a medical procedure can expand markets. This minimally invasive technology platform can help change perceptions and overcome reservations — opening aesthetics to the many women who would not consider a traditional surgery. We are also extremely gratified that all Motiva implants and tools have now received certification under the new European MDR standard.”\n\n\nThe Motiva Channel Dissector, Balloon, and Injector are designed to be used in Establishment Labs’ next generation minimally invasive aesthetic procedures. Establishment Labs has now completed a full transition of all currently marketed Motiva implants and tools as well as the Company’s quality management systems to be in compliance with the new European Medical Device Regulation (MDR).\n\n\n“Medicine is often advanced with the development of innovative technology platforms that enhance the skill of the practitioner,” added Professor Marcos Sforza, plastic surgeon, lecturer, and researcher based in London, England. “These tools provide new capabilities that allow procedures to be performed more safely and predictably, resulting in better outcomes for our patients.”\n\n\nAbout Establishment Labs\n\n\nEstablishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The over three million Motiva® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Mot...