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Wire · operational-macro

SELUTION SLR™ Drug-Eluting Balloon Approved by FDA for In-Stent Restenosis

21 September 2026 · By · Wire by Fusion42

Published

21 September 2026

Topic

operational-macro

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at businesswire.com →

◆ Verified

Fusion42 · 21 September 2026 · Fusion42 review

The FDA has approved the SELUTION SLR™ Drug-Eluting Balloon, the first and only sirolimus drug-eluting balloon in the US, for treating coronary in-stent restenosis, providing a new treatment option for a complex cardiovascular condition.

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

◆ ◆ The Wire takeaway

You have a new FDA-approved sirolimus drug-eluting balloon to compete with or integrate in coronary restenosis treatment. This clears a regulatory hurdle that opens pathways for advanced medtech startups targeting cardiovascular interventions.

◆ Coverage

1 source · 21 Sep 2026

◆ Related on Wire

◆ Topics

Medtechfda-approvalcardiovasculardrug-eluting-balloonsirolimusmedtech-innovation