Motiva Flora features the SmoothSilk surface, which is a bioengineered nanosurface that has showed a low rate of capsular contracture
Medical technology company Establishment Labs Holdings has secured CE mark approval for its Motiva Flora Tissue Expander.
Featuring SmoothSilk surface, the Motiva Flora Tissue Expander is claimed to be the only product with an integrated RFID port with no magnets, enabling to use expander safely alongside MRI scanning.
Motiva Flora and Motiva Implants feature the SmoothSilk surface, which is a bioengineered nanosurface that has showed a low rate of capsular contracture and no reported cases of BIA-ALCL to date, said the company.
The company will immediately start pre-marketing activities of Motiva Flora in Europe
Establishment Labs aims to immediately begin pre-marketing activities in Europe for Flora, while broad commercial activities in early 2021. The Motiva Flora Tissue Expander is not yet approved or commercialised in the US.
In March 2018, Establishment Labs secured approval for an investigational device exemption (IDE) from the US Food and Drug Administration (FDA). The company commenced the Motiva Implant clinical trial in the US in April 2018.
Establishment Labs CEO Juan José Chacón Quirós said: “We are pleased that oncologists, plastic surgeons and patients will now have access to advanced, patented and patent pending technology that offers substantial improvements over existing tissue expander products.
“Motiva Flora is another example of our unwavering commitment to women’s health as we continue to transform the breast aesthetics and reconstruction industry through science and innovation.”
Establishment Labs is engaged in the designing, development, manufacturing and marketing of an advanced portfolio of silicone gel-filled breast implants.
The Motiva Implants, which are manufactured at two manufacturing sites, are currently commercially available in over 80 countries through exclusive distributors or the company’s direct salesforce.
The company’s product and technologies portfolio are also comprised of Divina 3D simulation system and other products and services.
In April, US-based medical device company Cerus Endovascular secured CE Mark approval for its Neqstent Coil Assisted Flow Diverter device.