Establishment Labs has begun the process of gaining FDA approval by submitting an Investigational Device Exemption (IDE) filing to the U.S. Food and Drug Administration (FDA) for its Motiva Implants®.  Upon acceptance, the IDE would enable the Company to initiate a clinical study in the U.S. to assess the safety profile and patient satisfaction of Motiva Implants.

Juan José Chacón-Quirós, CEO and founder of Establishment Labs said “Motiva Implants are already sold in over 60 countries worldwide and have been implanted more than 300,000 times over the past seven years. We are confident that a clinical study in the United States will confirm the safety profile we are seeing in all of our markets.”

In our pilot study, we were able to prove that, compared to a smooth surface control, Establishment Labs’ SilkSurface decreases fibrosis-dependent-innate immune macrophages,” said Professor Langer. “We will continue to work in collaboration with the scientists at Establishment Labs to further evaluate the fibrotic response mechanism in breast implant surfaces,” he added.

With its cone-shaped design and its Hyaluronic Acid coating, the Motiva Insertion Sleeve, manufactured by Keller, provides a shell-tissue interface that reduces friction during insertion of the implant, gently delivers it into the surgical pocket and allows for a no or low-touch delivery technique. The Motiva specific trim guideline fully exploits the unique properties of Motiva Ergonomix Implants to allow for Minimally Invasive insertions.