Establishment Labs announced the completion of their enrollment in the Motiva US IDE clinical study. The final surgery in the primary reconstruction cohort was finished at Northwestern Memorial Hospital. The Augmentation cohort, which completed enrollment in August, 2019, will complete their third year of the study follow-up this August.
The Motiva US IDE study enrolled a total of 827 patients at 32 various centers in the US, Germany and Sweden. The authors assessed the safety and effectiveness of Motiva breast implants in primary breast augmentation, breast reconstruction and revision breast surgeries.
“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 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 study has 562 patients in the augmentation cohorts and 265 in the reconstructive cohorts. A Magnetic Resonance Imaging (MRI) cohort of 250 patients was also included in the study. Those patients will receive MRIs at years, one, two, three, five, seven and 10 to asses for any silent ruptures.