---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-269378"
form_type: "8-K"
ticker: "MDT"
cik: "0001613103"
company_name: "Medtronic plc"
filed_at: "2021-09-10T23:59:59+00:00"
generated_at: "2026-06-29T04:33:33.830694+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Medtronic updates SPYRAL HTN-ON MED study timeline; interim analysis in late October

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-21-269378
- form_type: 8-K
- ticker: MDT
- cik: 0001613103
- company_name: Medtronic plc
- filed_at: 2021-09-10T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613103/000119312521269378/0001193125-21-269378-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613103/000119312521269378/d232210d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-269378
- JSON: https://secwatch.observer/filing/0001193125-21-269378.json
- Plain text: https://secwatch.observer/filing/0001193125-21-269378.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.