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Cardiovascular device

Selution SLR in Coronary In-Stent Restenosis: market forecast and verdict

Cordis · FDA premarket approval announced 21 September 2026 · Breakthrough Device · sold in 65+ countries

OUR VERDICTA credible second entrant in a niche, with the larger prize still ahead.Matching standard care in in-stent restenosis lets Cordis challenge Agent, but the bigger market of small de novo vessels depends on a trial of 960 patients still to report.
~USD 68M
Base case US revenue, 2031, in-stent restenosis onlyRange USD 33M to 145M · Zaash Labs estimate
~65,000
US in-stent restenosis PCIs a year, Zaash Labs estimate
15.2% vs 13.5%
target lesion failure at 12 months vs standard care, non-inferior
960
patients in SELUTION4DeNovo, enrollment complete

What was approved and why it matters

Cordis' Selution SLR is a balloon that releases sirolimus into the artery wall for up to 90 days, treating narrowing inside an existing stent without leaving another implant behind. It is the first sirolimus-eluting balloon approved in the US and the second coronary drug-coated balloon, after Boston Scientific's Agent.

Frequently asked questions

When was Selution SLR approved?

Cordis announced FDA premarket approval of Selution SLR for coronary in-stent restenosis on 21 September 2026.

What are Selution SLR's projected sales?

Zaash Labs' base case is about USD 68 million of US revenue in 2031 from in-stent restenosis alone. Approval in small de novo vessels could lift that toward USD 145 million.

How does Selution SLR compare with Agent?

Agent, a paclitaxel coated balloon from Boston Scientific, was approved for in-stent restenosis in March 2024 and already has dedicated Medicare payments. Selution uses sirolimus and was non-inferior to standard care, mostly drug-eluting stents, in SELUTION4ISR.

Figures are company reported or from published sources unless marked as Zaash Labs estimates. Sources are listed in the executive summary and the full report. Market research to support business decisions; not investment advice.