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Establishment Labs Notes Presentation of 5-Year Results from Motiva U.S. IDE Study at The Aesthetic MEET 2025
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, noted the presentation today of an update on the Motiva US IDE Study. The update will include five-year patient follow-up data for primary augmentation subjects. The Medical Director of the Study, Dr. Caroline Glicksman, who is also an Investigator in the Study, will present the results at The Aesthetic MEET 2025, the annual meeting of The Aesthetic Society, in Austin, Texas.\n\nDr. Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the five-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at four years was 88.5%. The five-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\nPrimary Augmentation\n\n\n\n5-year (N=451), 95% CI\n\n\n\n\n\nCapsular contracture (Baker Grade III/IV)\n\n\n\n0.5%\n\n\n\n\n\nRupture, suspected or confirmed; MRI cohort1\n\n\n\n0.6%\n\n\n\n\n\nBreast pain\n\n\n\n1.2%\n\n\n\n\n\nInfection\n\n\n\n0.9%\n\n\n\n\n\nImplant removal, with or without replacement\n\n\n\n3.1%\n\n\n\n\n\nAny reoperation2\n\n\n\n8.8%\n\n\n\n\n\nAny complication3\n\n\n\n12.0%\n\n\n\n\n\n\n1.\n\n\n\n\nMRI cohort N=176\n\n\n\n\n\n2.\n\n\n\n\nAny surgery on the breast or chest area, device or non-device related, including size change\n\n\n\n\n\n3.\n\n\n\n\nAny device or non-device related event, including reoperation\n\n\n\n\nCommenting on the results, Dr. Glicksman said, “At the mid-point of the ten-year core study, Motiva implants continue to show low rates of complication. The consistency in these clinical results is particularly notable, as we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture since we began reporting at two years. Overall, patient follow-up remains very high, and the rates of complication remain very low. I am proud to be part of this important ongoing study.”\n\nEstablishment Labs received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast impl...