Virtue® SEB

Virtue® SEB demonstrated compelling safety and efficacy data

  • Virtue® SEB demonstrated compelling safety and efficacy in SABRE (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis), 50-patient prospective multi-center study evaluating Virtue® SEB in patients with coronary in-stent restenosis (ISR)
    • Efficacy: Late Loss of 0.12mm (per protocol population)
    • Safety: 0.0% Major Adverse Cardiac Events (MACE) in hospital, 2.8% MACE at 6 months and 2.8% MACE at 1 year (per protocol population)
  • Angiographic results and 1-year clinical outcomes of the SABRE trial were published in JACC: Cardiovascular Interventions, October 2017

SABRE Angiographic Results - 6 months

Binary Restenosis = restenosis of ≥ 50% of lumen diameter; * Trial primary performance endpoint; ** RVD reported using Internormal values; # Trial secondary performance endpoint

SABRE Clinical Safety Outcomes

* Primary safety endpoint is 30 day TLF; MI: myocardial infarction CABG: coronary artery bypass gaft surgery; TLR: any repeat percutaneous or surgical intervention of target lesion; TLF: target lesion failure; MACE: per patient composite of death, MI, CABG, and TLR
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