---
schema_version: "secwatch.filing_event.v1"
accession: "0001613103-21-000047"
form_type: "8-K"
ticker: "MDT"
cik: "0001613103"
company_name: "Medtronic plc"
filed_at: "2021-10-15T23:59:59+00:00"
generated_at: "2026-06-28T20:34:32.396356+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Medtronic SPYRAL HTN-ON MED study DSMB recommends trial continuation; full cohort follow-up expected H2 2022

## Summary
- DSMB prespecified interim analysis recommends ON MED clinical trial enrollment continue until full sample size of 260 patients is reached.
- Full cohort follow-up expected in H2 2022; trial powered to detect statistically significant therapeutic benefit at final analysis.
- Medtronic reiterates FY2022 revenue and EPS guidance; long-range plan of 5%+ organic revenue growth and 8%+ adjusted EPS growth unchanged.
- Company projects global renal denervation market exceeding $500M by 2026 and $2-3B by 2030.

## SEC filing metadata
- accession: 0001613103-21-000047
- form_type: 8-K
- ticker: MDT
- cik: 0001613103
- company_name: Medtronic plc
- filed_at: 2021-10-15T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613103/000161310321000047/0001613103-21-000047-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613103/000161310321000047/mdt-20211015.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001613103-21-000047
- JSON: https://secwatch.observer/filing/0001613103-21-000047.json
- Plain text: https://secwatch.observer/filing/0001613103-21-000047.txt

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