Ergonomix2 features advanced ultra-high purity chemistries for improved device mechanical properties and enhanced patient ergonomics
Medical technology company Establishment Labs Holdings has secured CE mark approval for its next-generation Motiva Ergonomix2 silicone breast implant platform.
The company’s Motiva Ergonomix2 Diamond breast implant has also received CE mark approval, which is suitable for use in the Motiva Mia minimally invasive breast augmentation system when it is approved.
Ergonomix2 features the company’s latest innovations, including its advanced ultra-high purity chemistries for improved device mechanical properties and enhanced patient ergonomics.
The implant is also provided with the firm’s patented SmoothSilk surface technology, which is the basis of Motiva Implants’ low inflammatory characteristics.
Ergonomix2 is CE marked for use in both aesthetic and reconstruction procedures
Establishment Labs has CE mark labeling for Ergonomix2 to be used in both aesthetic and reconstruction procedures.
Motiva Implants, Motiva Ergonomix2, Motiva Ergonomix2 Diamond and the Motiva Mia system have not yet approved for commercial distribution in the US.
Establishment Labs stated that Motiva Implants are undergoing clinical assessment pursuant to US FDA regulations for investigational medical devices.
Establishment Labs founder and CEO Juan José Chacón-Quirós said: “This regulatory approval will enable Establishment Labs to bring the next generation of our best-selling Motiva Ergonomix implant to Europe in the first half of 2021 followed by a broad commercial launch later in the year.
“Equally important, the inclusion of the Motiva Ergonomix2 Diamond breast implant in this CE mark shortens our European regulatory approval timeline for the Motiva Mia system by as much as three years. We are now expecting the first pre-commercial Motiva Mia procedures in Europe to begin in the second half of 2021.”