Virtue® SEB

Virtue® SEB Demonstrated Compelling Safety andEfficacy Results in Patients with ClinicalFollow-Up out to 3 Years

Figure 1: SABRE Angiographic Results - 6 Months

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

Figure 2: SABRE Clinical Safety Outcomes

sabre clinical safety* 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
** Cause of death unknown - reported as multiple organ failure non cardiac and non-neurological. Adjudicated as non-device and non-procedure related.

Revised per protocol analysis set meets the criteria of the proposed In-Stent Restenosis IDE study population. For more detailed information on study data and different analyses, please refer to 3-year SABRE Clinical Report.
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