Establishment Labs says update on Motiva U.S. IDE study presented

Establishment Labs noted the presentation of a study update on the Motiva US IDE Study. The update included three-year patient follow-up data for primary augmentation subjects. The Medical Director of the Study, Dr. Caroline Glicksman, who is also a Principal Investigator in the Study, presented the results today at Aesthetic Surgery Education and Research Foundation, or ASERF, Premier Global Hot Topics session as part of The Aesthetic Meeting 2023. Dr. Glicksman presented data for the 451 primary augmentation patients enrolled in the study through the three-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at three years was 92.4%. "The Motiva US IDE study is still in follow-up, but the consistency in clinical outcomes from year two to year three are notable, with no increase in capsular contracture or the number of patients with suspected or confirmed rupture, including in the MRI cohort. The preliminary results and the continued high rates of patient follow-up remain encouraging. These results are the latest evidence of the performance of Motiva implants, adding to data collected over twelve years and from over three million implants placed in markets globally. The clinical results presented today have been submitted to the FDA as part of the final module of the PMA, and we look forward to this new standard in breast implants being made available to women in the United States," said Dr. Glicksman.