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FDA approvedFDA approved. Stage 4 of 4 (Authorized)

FDA Approves Cordis' Selution SLR, First Sirolimus Balloon Approved in the US for In-Stent Restenosis

The premarket approval rests on a noninferiority trial against mostly repeat stenting; the device missed a secondary endpoint in single-layer restenosis.

By News DeskSeptember 21, 20262 min read
Medical illustration of a balloon catheter inflated inside a narrowed artery
Illustration of an angioplasty balloon inflating inside an artery. Not the Selution SLR device described in this article. Blausen Medical Communications, CC BY 3.0, via Wikimedia Commons · CC BY 3.0
FDA approvedPMA, high-risk device · P250041FDA approved. Stage 4 of 4 (Authorized)

The FDA approved this high-risk device through premarket approval (PMA), after reviewing clinical evidence of safety and effectiveness.

Key points

  • The FDA approved PMA P250041 for the SELUTION SLR 014 PTCA Drug-Eluting Balloon on September 18, 2026; Cordis announced it on September 21.
  • In the SELUTION4ISR trial, target lesion failure at 12 months was 15.2% with the balloon versus 13.5% with standard care across all randomized patients, meeting the noninferiority goal.
  • Cordis said US physicians have immediate access and that a 960-patient trial in small coronary vessels has finished enrolling.

The FDA has approved Cordis' Selution SLR drug-eluting balloon for treating coronary in-stent restenosis, making it the first sirolimus-coated balloon approved in the United States, the company announced on September 21, as reported by Cardiac Interventions Today and MedTech Dive.

The FDA's premarket approval database lists PMA P250041 for the "SELUTION SLR™ 014 PTCA Drug-Eluting Balloon," filed by MedAlliance, LLC of Irvine, California, on October 29, 2025, with a decision date of September 18, 2026. The record classifies it as a drug-eluting percutaneous transluminal coronary angioplasty catheter, product code OOB, and identifies it as a combination product.

What was approved

According to the approval order statement, the balloon "is intended to be used after appropriate vessel preparation in patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.25 mm to 4.50 mm in diameter," in lesions up to 26 mm long, "for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR)."

In-stent restenosis is the renarrowing of an artery that has already been stented. Cordis said Selution SLR is designed to release sirolimus for up to 90 days without leaving a permanent implant behind, Cardiac Interventions Today reported. The company said the device had previously received FDA breakthrough device designation and has been sold in more than 65 countries.

Selution SLR is not the first drug-coated balloon in the US market: MedTech Dive noted that Boston Scientific won FDA approval for its paclitaxel-coated Agent balloon in 2024, after comparing it with an uncoated balloon.

The SELUTION4ISR trial

The approval rests on SELUTION4ISR, a randomized, single-blind noninferiority trial that enrolled more than 400 patients at 48 sites in the US, Canada, Brazil and Europe, according to the company as reported by Cardiac Interventions Today. The comparator was standard of care, about 80% of which was repeat drug-eluting stents. The FDA record links the approval to trial NCT04280029.

The trial met its primary noninferiority endpoint at 12 months: per protocol, target lesion failure was 16.2% with Selution SLR and 14.5% with standard care, and across all randomized patients the rates were 15.2% and 13.5%, the company said. The results were presented by co-principal investigator Donald Cutlip at TCT 2025.

MedTech Dive reported that the trial missed a secondary endpoint in patients with single-layer in-stent restenosis, where target lesion failure was 14.2% with Selution SLR and 6.5% with standard care.

"Supported by randomized evidence from the SELUTION4ISR trial, the Selution SLR sirolimus DEB allows us to treat ISR without necessarily adding another permanent layer of metal," Cutlip said in the company's release.

Launch and next indication

Cordis said US physicians will have immediate access to the device. The company also said it has completed enrollment in SELUTION4DeNovo, a 960-patient randomized investigational device exemption trial comparing the balloon with drug-eluting stents in small coronary vessels, which it intends to use to support a future premarket approval application.

Cordis acquired MedAlliance, Selution SLR's original developer, in 2023, MedTech Dive reported. Cardinal Health sold Cordis to private equity firm Hellman & Friedman in 2021, according to the outlet.

Sources

  1. Cordis' Selution SLR Drug-Eluting Balloon Approved by FDA for In-Stent Restenosis, Cardiac Interventions Today, September 21, 2026
  2. Cordis wins FDA approval for sirolimus-eluting balloon, MedTech Dive, September 21, 2026
  3. Premarket Approval P250041: SELUTION SLR 014 PTCA Drug-Eluting Balloon, US Food and Drug Administration, September 18, 2026