secwatch.observer — SEC 8-K summary
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Issuer:     ESTABLISHMENT LABS HOLDINGS INC. (ESTA)
CIK:        0001688757
Form:       8-K
Filed at:   2023-04-20T23:59:59+00:00
Accession:  0001104659-23-047762
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Establishment Labs reports 3-year Motiva IDE study data; capsular contracture rate 0.5%
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- 3-year follow-up on 451 primary augmentation patients; compliance 92.4%.
- Kaplan-Meier risk rates: capsular contracture 0.5%, rupture 0.6%, breast pain 0.7%, infection 0.9%.
- Any reoperation 6.1%, any complication 8.4% at 3 years.
- Data submitted to FDA as part of final PMA module; device not yet approved in US.
- Results consistent from year 2 to year 3 with no increase in capsular contracture or rupture.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1688757/000110465923047762/0001104659-23-047762-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1688757/000110465923047762/tm2313294d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-047762

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer