Establishment Labs this week announced it received CE mark approval for its Motiva Injector, Motiva Inflatable Balloon and Motiva Channel Dissector.
The company designed the three devices for its next-generation minimally invasive aesthetic procedures.
“The approval in Europe of our minimally invasive tools is an important step in the evolution of plastic surgery,” Founder and CEO Juan José Chacón-Quirós said in a news release. “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.”
Upon the CE mark approval, Establishment Labs has now completed a full transition of all currently marketed Motive 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,” said 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’ Motiva implants and tools are currently not approved for commercial distribution in the U.S. They are undergoing clinical investigation pursuant to the U.S. FDA regulations for investigational medical devices.