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SELUTION SLR™ DEB Wins US FDA Approval for In-Stent Restenosis
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Fusion42 · 5 October 2026 · Fusion42 review
The FDA has approved the SELUTION SLR™ sirolimus drug-eluting balloon for treating coronary in-stent restenosis in the US, marking the first approval of its kind. This approval follows extensive clinical trials and positions SELUTION SLR as a key alternative to paclitaxel-based treatments, expanding treatment options for around 10% of the one million annual coronary interventions in the US.
This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 22 Sep 2026 and 5 Oct 2026.
◆ ◆ The Wire takeaway
Us cardiology device founders should act now to revisit drug-coated balloon offerings, as sirolimus-based treatment now competes with paclitaxel options in the largest market. This unlocks new product development paths and sales tactics targeting stentless coronary care.
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2 sources · first reported 22 Sep 2026 · latest 5 Oct 2026
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