Establishment Labs Announces Full Enrollment in Motiva US IDE Study
SANTA BARBARA, Calif.–(BUSINESS WIRE)–Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving the health and well-being of women, primarily in the area of aesthetics and breast reconstruction, announced today that it has completed enrollment in the Motiva US IDE Clinical Study. The last surgery in the primary reconstruction cohort was performed at Northwestern Memorial Hospital. The Augmentation Cohort, which completed enrollment in August 2019, will complete its third year of study follow-up this month.
“Conducting such a rigorous FDA clinical trial during a global pandemic while maintaining a high level of patient follow-up is a testament to the dedication of the study surgeons, healthcare professionals, and facility labs,” said Dr. Caroline Glicksman, medical director of and researcher in the Motiva IDE study. “The entire investigation team can be proud of their efforts to provide women with access to new options in breast surgery.”
The Motiva US IDE study recruited 827 patients at 32 centers in the United States, Germany and Sweden. The study is designed to evaluate the safety and effectiveness of Motiva breast implants in primary breast augmentation, primary breast reconstruction and breast revision procedures. The study included 562 patients in the augmentation cohorts and 265 in the reconstruction cohorts. The study includes a magnetic resonance imaging (MRI) cohort of 250 patients who receive MRIs at years 1, 2, 3, 5, 7, and 10 to assess silent rupture.
“Having completed full enrollment in the IDE study in all patient groups, we are working diligently with the plastic surgeons in the trial to maintain high patient follow-up,” said Juan José Chacón-Quirós, Founder and CEO of Establishment Labs. “We are very pleased with our progress in the augmentation cohort, and expect to file our PMA submission with the FDA in the fourth quarter of this year for aesthetic indications.”
“Motiva implants have created a new standard in my practice for post-mastectomy reconstruction,” added Professor Dr. Phillip Blondeel, Professor of Plastic Surgery and Chairman of the Department of Plastic and Reconstructive Surgery at Ghent University Hospital, in Belgium ; President of the European Society of Plastic Surgery (EURAPS); and director of the Beautiful After Breast Cancer Foundation. “With Motiva, we can consistently achieve the aesthetic results that women hope for in their reconstruction, and in doing so, we are helping to turn breast cancer into a treatable disease that women can fully recover from.”
The pivotal Motiva Core study is an ongoing US clinical trial of an investigational medical device licensed by the FDA. Investigational Device Exemption. The Motiva device has not been approved by the Food and Drug Administration and is not commercially available in the United States.
About Institutional Laboratories
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving the health and well-being of women. The initial focus of the company is breast health, primarily aesthetics and breast reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded Motiva Implants®, that include a number of innovative, patented features designed to deliver better aesthetic and clinical outcomes. Since commercial launch in 2010, more than 2.0 million Motiva® implants have been delivered to plastic surgeons in more than 80 countries. The Company also offers or has in development a number of related products and technologies, including the Motiva Flora® tissue expander and Mía®, the Company’s minimally invasive breast enhancement procedure. In 2018, Establishment Labs received an Investigational Device Exemption (IDE) from the 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 factories in Costa Rica, which comply with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for more information at www.establishmentlabs.com.
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