SELUTION DeNovo Trial Demonstrates Non-Inferiority of SELUTION SLR(DEB) to Standard of Care in De Novo Lesions

Strategic Insights -

The largest randomized Drug Eluting Balloon trial, SELUTION DeNovo, has shown that a SELUTION SLR(TM) DEB treatment strategy is non-inferior to a systematic DES treatment strategy in real-world coronary de novo lesions. The trial, which enrolled 3,323 patients across 62 international sites, demonstrated a target vessel failure (TVF) rate of 5.3% at 12-months compared to 4.4% in the DES arm. This finding supports the use of SELUTION SLR(TM) DEB as an alternative to traditional DES treatment.

Key Takeaways:

  • SELUTION DeNovo trial, a randomized study with 3,323 patients across 62 international sites, demonstrated non-inferiority of SELUTION SLR(TM) DEB to standard of care in de novo lesions.
  • The SELUTION SLR(TM) DEB treatment strategy achieved TVF at 12-months of 5.3% compared to 4.4% in the DES arm.
  • Evidence from this study supports a SELUTION SLR(TM) DEB treatment strategy of de novo lesions as an alternative to traditional DES treatment.
  • Co-Principal Investigator, Professor Christian Spaulding, highlighted the paradigm shift in Percutaneous Coronary Intervention with SELUTION SLR(TM) DEB, reducing the need for stents and providing effective and safe sirolimus drug-eluting balloon treatment.
  • SELUTION4ISR trial demonstrated non-inferior performance of SELUTION SLR(TM) DEB against ISR standard-of-care treatment, with a target lesion failure (TLF) rate of 15.2% at 12-months.
  • Cordis' commitment to innovation was highlighted through the SELUTION SLR(TM) DEB clinical portfolio with over 17,000 patients, advancing science and collaboration to transform cardiovascular treatment.
  • The SELUTION SLR(TM) DEB Commercially available in more than 65 countries and investigational in the U.S., is designed to provide controlled and sustained drug release through 90-days.

Statistics:

  • SELUTION DeNovo trial enrolled 3,323 patients across 62 international sites.
  • The SELUTION SLR(TM) DEB treatment strategy achieved a 5.3% TVF rate at 12-months.
  • The DES arm achieved a 4.4% TVF rate at 12-months.
  • The SELUTION4ISR trial demonstrated a 15.2% TLF rate at 12-months.

Sources:

  • Cordis press release, "Cordis Announces Groundbreaking Results from SELUTION DeNovo and SELUTION4ISR Trials at TCT 2025"
  • TCT 2025 scientific symposium
  • Cardiovascular Research Foundation (CRF)
  • SELUTION SLR(TM) DEB clinical portfolio