Establishment Labs Holdings Inc., a medical technology company focused on breast aesthetics and reconstruction, announces that it 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,” says Juan José Chacón-Quirós, Establishment Labs’ founder and CEO. “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.”
He adds, “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’ 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 follow the new European Medical Device Regulation, or MDR.
“Medicine is often advanced with the development of innovative technology platforms that enhance the skill of the practitioner,” adds professor Marcos Sforza, MD, a London-based, board-certified plastic surgeon, lecturer, and researcher. “These tools provide new capabilities that allow procedures to be performed more safely and predictably, resulting in better outcomes for our patients.”