Establishment Labs Notes Presentation Of 4-Year Results From Motiva U.S. IDE Study At The Aesthetic Meeting 2024
Establishment 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 four-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 Meeting 2024 in Vancouver, BC Canada.
Dr. Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the four-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at four years was 88.9%. The four-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:
| Primary Augmentation | 4-year (N=451), 95% CI | |
| Capsular contracture (Baker Grade III/IV) | 0.5% | |
| Rupture, suspected or confirmed; MRI cohort1 | 0.6% | |
| Breast pain | 0.9% | |
| Infection | 0.9% | |
| Implant removal, with or without replacement | 1.8% | |
| Any reoperation2 | 6.8% | |
| Any complication3 | 9.6% |
| 1. | MRI cohort N=176 | |
| 2. | Any surgery on the breast or chest area, device or non-device related, including size change | |
| 3. | Any device or non-device related event, including reoperation |
Commenting on the results, Dr. Glicksman said, "The consistency in these clinical results at four years is notable. Since we released the two-year data, we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture, including in the MRI cohort. Relative to historic benchmarks, patient follow-up remains very high and the rates of complication remain very low. The Motiva Implant PMA is under review by the FDA and we look forward to women in the United States having access to this new standard in breast implants very soon."
The Motiva Core pivotal study is an ongoing US clinical trial of an investigational medical device under an FDA-approved Investigational Device Exemption. Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States. This interim report describes preliminary data available to date and does not necessarily reflect final clinical results nor demonstrate the investigational device's safety and effectiveness for the United States trial. Accordingly, no conclusions should be drawn based on the information presented.