secwatch.observer — SEC 8-K summary
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Issuer:     Medtronic plc (MDT)
CIK:        0001613103
Form:       8-K
Filed at:   2021-09-10T23:59:59+00:00
Accession:  0001193125-21-269378
Event type: regulatory
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

Medtronic updates SPYRAL HTN-ON MED study timeline; interim analysis in late October
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- Prespecified interim look at ON MED study data by independent monitoring board scheduled for late October.
- If primary endpoint achieves statistical significance, trial investigators can present at TCT in early November.
- ON MED study will not be on TCT late-breaking clinical trial agenda due to late October data timing.
- Company working with CRF to ensure data is featured at TCT if endpoint met; enrollment will cease if significant.
- If primary endpoint not significant at interim, enrollment will continue to full predefined sample size.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1613103/000119312521269378/0001193125-21-269378-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1613103/000119312521269378/d232210d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-269378

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