Medical technology company Establishment Labs has received a CE mark for its minimally invasive surgical tools designed for use in aesthetic surgery procedures.
The approved surgical tools include the Motiva inflatable balloon, Motiva channel dissector, as well as Motiva injector.
These devices were approved under the European Medical Device Regulation (MDR).
Establishment Labs founder and CEO Juan José Chacón-Quirós said: “The approval in Europe of our minimally invasive tools is an important step in the evolution of plastic surgery. 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.”
The three Motiva devices are intended for use in the company’s next-generation minimally invasive aesthetic procedures.
Furthermore, the company has fully complied with the requirements of the new European MDR by transitioning all existing Motiva implants, tools and quality management systems.
UK-based plastic surgeon and researcher Professor Marcos Sforza said: “Medicine is often advanced with the development of innovative technology platforms that enhance the skill of the practitioner.
“These tools provide new capabilities that allow procedures to be performed more safely and predictably, resulting in better outcomes for our patients.”
Establishment Labs offers a range of femtech solutions for breast aesthetics, reconstruction and health.
The company’s Motiva Flora tissue expander is claimed to be the world’s only regulatory-approved magnetic resonance imaging conditional expander with an integrated port.
It is designed to enhance outcomes in the breast reconstruction process after breast cancer.