1. 505-0100.21, Operator's Manual, Core Integrated, 3.4X (p. 18); 505-0101.16, Operator's Manual, s5 Series FFR_iFR Option, v3.4x (p.15).
2. VAL RPT, S5-Core V3.4 SW with Core Control Pad, 215-0007.02.
3. Product Spec. 809480-001, 202-0407.01.
4. Requirements Specification Meridian VH SW, 806000-004 (pg 84).
5. An iFR cut-point of 0.89 matches best with an FFR ischemic cut-point of 0.80 with a specificity of 87.8% and sensitivity of 73.0%. (iFR Operator’s Manual 505-0101.23)
6. N Engl J Med. 2012;367(11):991-1001.
7. Witzenbichler B et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents: The ADAPT-DES Study. Circulation 2014 Jan: 129,4;463-470
8. Ahn et al. Meta-Analysis of Outcomes After Intravascular Ultrasound Guided Versus Angiography-Guided Drug-Eluting Stent Implantation in 26,503 Patients Enrolled in Three Randomized Trials and 14 Observational Studies. Am J Cardiol 2014; 113:1338-1347
9. Nair A, Margolis M, Kuban B, Vince D. Automated Coronary Plaque Characterisation with Intravascular Ultrasound Backscatter: Ex Vivo Validation. EuroIntervention. 2007; 3: 113-120
*Safety and efficacy of VH IVUS for use in the characterization of vascular lesions and tissue types has not been established
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