Establishment Labs Announces Complete Enrollment in Motiva US IDE Study
4 August 2022
Establishment Labs Holdings Inc. a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has completed enrollment in the Motiva US IDE clinical study. The final surgery in the primary reconstruction cohort was completed at Northwestern Memorial Hospital. The Augmentation cohort, which finished enrollment in August of 2019, will complete its third year of study follow-up this month.
“Completing 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, medical professionals, and Establishment Labs,” said Dr. Caroline Glicksman, Medical Director of and Investigator in the Motiva IDE Study. “The entire investigative team can be proud of their efforts to provide women access to new options in breast surgery.”
The Motiva US IDE study enrolled 827 patients at 32 centers in the US, Germany, and Sweden. The study is designed to assess the safety and effectiveness of Motiva breast implants in primary breast augmentation, primary breast reconstruction, and revision breast procedures. The study included 562 patients in the augmentation cohorts and 265 in the reconstructive 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 for silent rupture.
“Having completed full enrollment in the IDE study across all patient groups, we are diligently working 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 we expect to file our PMA submission with the FDA in Q4 of this year for the aesthetic indications.”
“Motiva implants have created a new standard in my practice for post-mastectomy reconstruction,” added Prof. Dr. Phillip Blondeel, Professor of Plastic Surgery and chairman of the Department of Plastic and Reconstructive Surgery at the University Hospital Gent, Belgium; President of European Society of Plastic Surgery (EURAPS); and Director of the Beautiful After Breast Cancer Foundation. “With Motiva, we can routinely achieve the aesthetic outcomes that women hope for in their reconstruction and in doing so, we are helping transform breast cancer into a treatable disease from which women can fully recover.”
The Motiva Core pivotal study is an ongoing US clinical trial of an investigational medical device under an FDA-approved 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 Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness. The company’s initial focus is 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 innovative and patented features designed to deliver improved aesthetic and clinical outcomes. Since commercial launch in 2010, over 2.0 million Motiva Implants® have been delivered to plastic surgeons in over 80 countries. The company also offers or has under 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 facilities in Costa Rica, which are compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for additional information at www.establishmentlabs.com.
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