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Establishment Labs Notes Presentation of 3-Year Results from Motiva U.S. IDE Study at The Aesthetic Meeting 2023
NEW YORK--(BUSINESS WIRE)-- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and
About this update from Establishment Labs Holdings Inc.
[{"type":"text","content":" NEW YORK--(BUSINESS WIRE)--\nEstablishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today 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 (ASERF) Premier Global Hot Topics session as part of The Aesthetic Meeting 2023 in Miami, Florida.\n\n\nDr. 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 three-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows:\n\n\n\n\nPrimary Augmentation\n\n\n\n\n\n\n3-year (N=451), 95% CI\n\n\n\n\n\n\n\n\nCapsular contracture (Baker Grade III/IV)\n\n\n\n\n\n\n0.5%\n\n\n\n\n\n\n\n\nRupture, suspected or confirmed; MRI cohort1\n\n\n\n\n\n\n0.6%\n\n\n\n\n\n\n\n\nBreast pain\n\n\n\n\n\n\n0.7%\n\n\n\n\n\n\n\n\nInfection\n\n\n\n\n\n\n0.9%\n\n\n\n\n\n\n\n\nImplant removal, with or without replacement\n\n\n\n\n\n\n1.6%\n\n\n\n\n\n\n\n\nAny reoperation2\n\n\n\n\n\n\n6.1%\n\n\n\n\n\n\n\n\nAny complication3\n\n\n\n\n\n\n8.4%\n\n\n\n\n\n\n\n1. MRI cohort N=176\n2. Any surgery on the breast or chest area, device or non-device related, including size change\n3. Any device or non-device related event, including reoperation\n\n\n“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,” said Dr. Glicksman. “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 res...