Establishment Labs Surpasses 3 Million Motiva Devices Milestone

Establishment Labs Holdings Inc. has sold more than 3 million Motiva devices over the last 13 years.
 
“Since its founding, Establishment Labs has been guided by one core principle: putting women at the center of everything we do,” Establishment Labs Founder/CEO Juan José Chacón-Quirós said. “We let science, engineering, and evidence drive our research and development, and this is reflected in the outstanding performance of our portfolio of solutions for breast aesthetics and reconstruction. By leading with innovation for over twelve years now, we have transformed the future of this industry.”
 
“The superior performance of Motiva is seen in our internal registries and warranty claims, as well as from independent registries and peer-reviewed publications, all of which are referenced in our annual Post Market Surveillance report,” said Dr. Heather Brennan, general manager, Global Markets. “Our expectations for continued growth are clear: with our new Sulàyöm Campus, which is opening in July, we are more than doubling our manufacturing capacity to address the growing demand for Motiva. We believe that by setting new standards in safety and clinical performance, we will expand markets in breast aesthetics and reconstruction.”
 
Establishment Labs’ 2022 Post Market Surveillance Report is available at: Motiva PMS Report. Motiva Implants are undergoing an IDE clinical trial and are not approved for sale in the United States.
 
Establishment Labs Holdings Inc. is a global medical technology company that offers a portfolio of femtech solutions for breast health, breast aesthetics, and breast reconstruction. The more than 3 million Motiva devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the more than 85 countries in which they are available. The Motiva Flora tissue expander is the only regulatory-approved expander in the world with an integrated port that is MRI conditional and is used to improve outcomes in breast reconstruction following breast cancer. Mia Femtech, Establishment Lab’s minimally invasive experience for breast harmony, is the company’s most recent breakthrough innovation. These solutions are supported by more than 200 patent applications in 25 separate patent families worldwide and over 50 scientific studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. In 2018, the company received an investigational device exemption (IDE) from the U.S. Food and Drug Administration for Motiva Implants and began a clinical trial to support regulatory approval in the United States.