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FDA premarket approval · Cordis · Cardiology

SELUTION SLR Drug-Eluting Balloon

FDA approves a sirolimus drug-eluting balloon for coronary in-stent restenosis.

CompareCordis press release
Approved · PMABreakthrough device

SELUTION SLR Drug-Eluting Balloon

Cordis · Cardiology · First sirolimus drug-eluting balloon in U.S.

Type
Therapy device
FDA route
Premarket approval (PMA)
Used by
Interventional cardiologists
Bottom line for your practice
50s read

Interventional cardiologists have a sirolimus balloon option for in-stent restenosis that, per the company, helps minimize the need for another stent. The supporting trial showed non-inferiority to standard of care, which was mostly repeat drug-eluting stenting.

What it is
A coronary angioplasty balloon that delivers sirolimus to the vessel wall. It is designed to provide sustained drug release for up to 90 days without leaving a permanent implant behind.
Indicated for
Patients with coronary in-stent restenosis.
What changes
The SELUTION4ISR trial compared the balloon against standard of care, including 80% drug-eluting stents. The company describes it as a way to treat in-stent restenosis without leaving another permanent implant.
Evidence
Head-to-head randomized trialSELUTION4ISRAt 12 months the study met its primary endpoint of non-inferiority in the per protocol population (16.2% for SELUTION SLR vs 14.5% for standard of care). In all randomized patients, target lesion failure rates were 15.2% for SELUTION SLR and 13.5% for standard of care.Randomized against an active treatment: the most direct evidence on how it compares with an existing option.
Watch for
The release does not list contraindications, warnings or adverse events. The trial was a single-blind non-inferiority study, and the approval covers in-stent restenosis only; a separate 960-patient trial in de novo small-vessel lesions has completed enrollment but is not part of this approval.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.Breakthrough Device designation: for devices that may offer more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. It speeds the FDA's interaction and review. It does not lower the standard for authorization.

Clinical summary

SELUTION SLR is a sirolimus drug-eluting balloon for the treatment of coronary in-stent restenosis, designed to deliver sustained drug release without leaving a permanent implant. In the SELUTION4ISR randomized trial of more than 400 patients, the primary non-inferiority endpoint was met at 12 months (per protocol 16.2% vs 14.5%); in all randomized patients, target lesion failure was 15.2% with the balloon and 13.5% with standard of care. The trial tested non-inferiority, not superiority, and the release gives no safety details.

From the source 11

Cordis press release

The Cordis press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. MIAMI LAKES, Fla., [September 21, 2026] — Cordis, a global leader in interventional cardiovascular and endovascular technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR), marking a major milestone in expanding treatment options for one of the most complex challenges in interventional cardiology.

    Backs · Date 2026-09-21 is the announcement date (the release does not state the FDA decision date)

  2. openFDA PMA record: "pma_number": "P250041", "trade_name": "SELUTION SLR 014 PTCA Drug-Eluting Balloon", "decision_date": "2026-09-18", "decision_code": "APPR"

    Backs · Pathway PMA. The release says 'approved' but does not name the pathway for this approval; confirmed in the FDA PMA database via openFDA (https://api.fda.gov/device/pma.json?search=pma_number:P250041), which also gives a decision date of 2026-09-18

  3. As the first and only sirolimus drug-eluting balloon approved in the United States, SELUTION SLR™ DEB introduces a groundbreaking therapy for the treatment of coronary ISR.

    Backs · First claim: first and only sirolimus drug-eluting balloon approved in the United States

View all 11 lines

  1. Designated as a Breakthrough Device, SELUTION SLR™ DEB is supported by results from the SELUTION4ISR trial, a prospective, multicenter, randomized, single-blind, controlled non-inferiority study that evaluated SELUTION SLR™ DEB against standard of care (SOC), including 80% drug-eluting stents, in patients with coronary ISR.

    Backs · Breakthrough Device; SELUTION4ISR design; 80% drug-eluting stents in control arm

  2. The trial enrolled more than 400 patients across 48 sites in the United States, Canada, Brazil, and Europe.

    Backs · More than 400 patients, 48 sites

  3. At 12 months the study met its primary endpoint of non-inferiority in the target population

    Backs · Primary endpoint met at 12 months

  4. 1. The primary endpoint was Per Protocol (SELUTION SLR DEB16.2% vs SOC 14.5%).

    Backs · Per protocol primary endpoint 16.2% vs 14.5%

  5. In all randomized patients, target lesion failure rates were 15.2% for SELUTION SLR™ and 13.5% for SOC.

    Backs · Target lesion failure 15.2% vs 13.5% in all randomized patients

  6. Commercially available in more than 65 countries and used in the treatment of over 250,000 patients worldwide, SELUTION SLR™ DEB is designed to provide Sustained Limus Release (SLR) for up to 90 days without leaving behind a permanent implant.

    Backs · Sustained release for up to 90 days, no permanent implant

  7. Beyond ISR, Cordis is proud to announce the completed enrollment in the SELUTION4DeNovo IDE trial, a 960-patient randomized study evaluating SELUTION SLR™ DEB versus drug-eluting stents for the treatment of de novo lesions in small coronary vessels in support of a future FDA premarket approval application.

    Backs · 960-patient de novo trial is separate and for a future application

  8. The availability of SELUTION SLR™ DEB in the United States is meaningful for interventional cardiologists because it provides an effective and highly deliverable sirolimus-based treatment option while helping minimize the need for another stent.

    Backs · Operator: interventional cardiologists; minimizes need for another stent

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