CE Mark Approval Granted to Establishment Labs’ MI Surgical Tools

Establishment Labs Holdings Inc. has received CE marking under the European Medical Device Regulation for the Motiva Injector, the Motiva Inflatable Balloon, and the Motiva Channel Dissector.
 
“The approval in Europe of our minimally invasive tools is an important step in the evolution of plastic surgery,” Establishment Labs Founder/CEO Juan José Chacón-Quirós said. “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.”
 
The 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).
 
“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.”
 
Establishment 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 more than 3 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 Motiva Flora tissue expander is the only regulatory-approved expander in the world with an integrated port that is MRI conditional and is used to improve outcomes in breast reconstruction following breast cancer. Mia Femtech, Establishment Lab’s unique minimally invasive experience for breast harmony, is the company’s most recent breakthrough innovation. These solutions are supported by more than 200 patent applications in 25 separate patent families worldwide and over 50 scientific studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. In 2018, the company received an investigational device exemption (IDE) from the FDA for Motiva Implants and began a clinical trial to support regulatory approval in the United States.