418
Patients

48
Sites across the U.S., 
Canada, Brazil and 
Europe

1:1
Randomization

5-Year
Follow-Up 

SELUTION SLRTM Drug-Eluting Balloon (DEB) is an effective alternative to standard of care in ISR, minimizing metal.

The only coronary drug-eluting balloon evaluated for ISR with a standard-of-care control (SOC) that included 80% Drug-Eluting Stents (DES).

SELUTION4ISR Trial Results

3,323
Patients

62
Sites across Europe and Asia

1:1
Randomization

5-Year
Follow-Up 

SELUTION SLR DEB Strategy is non-inferior to DES Strategy.

SELUTION DeNovo Trial: Subgroup Analyses 

Complex PCI3
835 patients

7.2% 
TVF at 12 months DEB Strategy
vs.
10.2%
DES strategy

View Analysis

High Bleeding Risk4
522 patients

4.9% 
TVF at 12 months DEB Strategy
vs.
7.9%
DES Strategy

View Analysis

Acute Coronary Syndrome5
1,082 patients

5.3% 
TVF at 12 months DEB Strategy
vs.
4.9%
DES Strategy

View Analysis

Operator Experience6
1,661 patients | DES arm

30%+
Reduction in provisional stenting 
with experience 

View Analysis

Real-World Evidence

Observational Study
LOVE-DEB Study7
Large de nova lesions  (≥2.75 mm) 
206 patients | 372 lesions

2.3% 
Clinically driven TLR at 12 months

0%
Abrupt vessel closure at 30 days

Registry
Malaysian Registry8
Real-world de nova lesions 
100 patients | 162 lesions

2.0%
TVF at 12 months

0%
Procedural or device-related deaths

Expanding Clinical Horizons

Multiple clinical trials are in development to evaluate SELUTION SLR DEB across 
additional vascular indications. (Coming soon)

Global SELUTION SLR DEB Registry

Real-world registry collecting real-world outcomes with SELUTION SLR DEB.
(Coming soon)

  1. Cutlip D, Mehran R, Sharma S, et al. Sirolimus-Eluting Balloon vs Repeat Drug-Eluting Stent or Balloon Angioplasty for Coronary In-Stent Restenosis. JACC 2026; 88(1); doi 10.1016 │ j.jacc.2026.03.021.
  2. Spaulding C, Krackhardt F, Bogaerts K, et al. Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial. Circulation 2026 Jul 21;154(3):185-197. DOI: 10.1161/CIRCULATIONAHA.126.079033.
  3. Eccleshall S, Bogaerts K, Briguori C, et al. Sirolimus-eluting balloons in complex PCI: evidence from the SELUTION DeNovo trial. Conference presentation at: EuroPCR 2026; 2026.
  4. Rissanen TT, Eccleshall S, Krackhardt F, et al. Sirolimus-eluting balloons for patients at high bleeding risk: evidence from the SELUTION DeNovo trial. Conference presentation at: European Society of Cardiology (ESC) Congress 2026; 2026; Munich, Germany.
  5. Ladwiniec A, Puymirat E, Curzen N, et al. Sirolimus-eluting balloon for patients with acute coronary syndrome: evidence from the SELUTION DeNovo trial. Conference presentation at: Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions; 2026.
  6. Spaulding C, Briguori C, Wanczura P, et al. Operator experience effect on sirolimus-eluting balloon (SEB) strategy for de novo coronary lesions: a sub-study of the SELUTION DeNovo trial. Oral presentation at: Cardiovascular Research Technologies (CRT) 2026; March 7–10, 2026; Washington, DC, USA.
  7. Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust. Large de-NOVo coronary artery disease treated with sirolimus drug-eluting balloon: prospective evaluation of safety and efficacy of SELUTION SLR drug-eluting balloon (LOVE-DEB Registry). ClinicalTrials.gov. NCT05915468.
  8. Rosman A, et al. In a real-world practice, how does SELUTION SLR perform? Updates from the Malaysian registry: evaluation of the SELUTION SLR sirolimus-eluting balloon for de novo coronary artery disease. Conference presentation at: EuroPCR 2025; May 22, 2025.