300004969171/B Page 17 of 148
Figure 4: False Lumen in the right iliac identified using ChromaFlo feature
Indications for Use
The Volcano Precision Guided Therapy System is used for the qualitative and quantitative
evaluation of vascular morphology in the coronary arteries and vessels of the peripheral
vasculature. It is also indicated as an adjunct to conventional angiographic procedures to
provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and
coronary vasculature; flow information can be an adjunct to other methods of estimating
blood flow and blood perfusion.
VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic
ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS
system is intended to semi-automatically visualize boundary features and perform spectral
analysis of RF ultrasound signals of vascular features that the user may wish to examine
more closely during routine diagnostic ultrasound imaging examinations.
The pressure feature is intended for use in all blood vessels, including coronary and
peripheral arteries, to measure intravascular blood pressure during diagnostic angiography
and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of
vascular morphology in the coronary arteries and vasculature. As an adjunct to
conventional angiographic procedures to provide an image of the vessel lumen and wall
structures. The pullback feature of the SpinVision (PIMr) withdraws the imaging core
within the protective sheath for a maximum of 15 cm.