Establishment Labs Holdings Inc., which develops breast aesthetics and reconstruction devices, announces that 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 in Chicago. The augmentation cohort, which finished enrollment in August 2019, will complete its third year of study follow-up in August.
“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,” says Caroline Glicksman, MD, 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 U.S., 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 an 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,” says 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 quarter four of this year for the aesthetic indications.”
“Motiva implants have created a new standard in my practice for post-mastectomy reconstruction,” adds Phillip Blondeel, MD, PhD, FCCP, 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; 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,” Blondeel says.
The Motiva Core pivotal study is an ongoing U.S. clinical trial of an investigational medical device under an FDA-approved Investigational Device Exemption. The Motiva device has not been approved by the FDA and is not commercially available in the United States.