Michael Barbella, Managing Editor01.20.23
Establishment Labs Holdings Inc.'s Motiva Implants and the Motiva Flora tissue expander have been approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and are reimburseable products for post-mastectomy reconstruction under the Japanese National Health System.
The first reconstruction patient in Japan was successfully treated with Motiva at Nagoya University Hospital.
“Launching Motiva Flora with Motiva Implants in the Japanese market is a significant step in changing the global standard in breast reconstruction,” Founder/CEO Juan José Chacón-Quirós said. “A core mission for Establishment Labs is to develop and commercialize technologies that improve women’s health. Providing Japanese women the ability to match tissue expanders and implant surfaces that are backed by scientific and clinical data is another example of that commitment.”
The Motiva Flora tissue expander offers several notable innovations, including Establishment Labs’ patented SmoothSilk surface technology as well as a RFID-enabled, non-magnetic integrated port, that offer potential improvements in imaging, treatment, and overall clinical outcomes and patient satisfaction. More than 2.5 million Motiva implants have been used in over 80 countries since Establishment Labs launched the products in 2010.
Establishment Labs Holdings Inc. is a global medical technology company focused on breast health, principally breast aesthetics and reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants that include a number of patented features designed to deliver improved aesthetic and clinical outcomes. The company also offers or has under development a number of related products and technologies, including the Motiva Flora tissue expander and Mia Femtech, the company’s minimally invasive breast enhancement procedure. In 2018, Establishment Labs received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the Motiva Implant and began a clinical trial to support regulatory approval in the United States. Motiva Implants are manufactured at the company’s two facilities in Costa Rica, which are compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program.
Motiva Implants and the Motiva Flora tissue expander are currently not approved for commercial distribution in the United States.
The first reconstruction patient in Japan was successfully treated with Motiva at Nagoya University Hospital.
“Launching Motiva Flora with Motiva Implants in the Japanese market is a significant step in changing the global standard in breast reconstruction,” Founder/CEO Juan José Chacón-Quirós said. “A core mission for Establishment Labs is to develop and commercialize technologies that improve women’s health. Providing Japanese women the ability to match tissue expanders and implant surfaces that are backed by scientific and clinical data is another example of that commitment.”
The Motiva Flora tissue expander offers several notable innovations, including Establishment Labs’ patented SmoothSilk surface technology as well as a RFID-enabled, non-magnetic integrated port, that offer potential improvements in imaging, treatment, and overall clinical outcomes and patient satisfaction. More than 2.5 million Motiva implants have been used in over 80 countries since Establishment Labs launched the products in 2010.
Establishment Labs Holdings Inc. is a global medical technology company focused on breast health, principally breast aesthetics and reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants that include a number of patented features designed to deliver improved aesthetic and clinical outcomes. The company also offers or has under development a number of related products and technologies, including the Motiva Flora tissue expander and Mia Femtech, the company’s minimally invasive breast enhancement procedure. In 2018, Establishment Labs received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the Motiva Implant and began a clinical trial to support regulatory approval in the United States. Motiva Implants are manufactured at the company’s two facilities in Costa Rica, which are compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program.
Motiva Implants and the Motiva Flora tissue expander are currently not approved for commercial distribution in the United States.