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Wire · opportunities

Medtronic drug-coated balloon gets FDA breakthrough status

1 October 2026 · By · Wire by Fusion42

Published

1 October 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at medtechdive.com →

◆ Verified

Fusion42 · 1 October 2026 · Fusion42 review

Medtronic's drug-coated balloon device has received FDA breakthrough status to be studied for treating peripheral artery disease below the knee, a condition that is difficult to treat.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

Your medtech innovation just gained faster US access with FDA breakthrough status on a tough-to-treat vascular condition. Use this window to accelerate trials and position your device for quicker adoption.

◆ Coverage

1 source · 1 Oct 2026

◆ Related on Wire

◆ Topics

MedtechmedtronicFDA-breakthroughperipheral-artery-diseasedrug-coated-balloonmedical-devices