Intravascular diagnostic TechniquesDevice NamesManufacturersFDA ClearanceDate of FDA Clearance
Fractional Flow Reserve (FFR)PressureWire™ Aeris Wireless FFR Measurement SystemSt. Jude MedicalYesApril 24 1998
PressureWire® Certus with RADIAnalyzer® Xpress monitorSt. Jude MedicalYesJuly 1 2008
(Pressure wire)

Oct 9 2009
(RadiAnalyzer Xpress)
Horizon Cardiology™McKessonYesNov 8 2006
OptoWireOpsens Inc.No
ComboMap® Pressure and Flow SystemVolcano CorporationYesJune 2 2004
Coronary Flow Reserve (CFR)FloWire® Doppler Guide WireVolcano CorporationYesNov 24 2004
Intravascular Ultrasound (IVUS)Volcano s5i™ Imaging SystemVolcano CorporationYesOct 8 2008
iCross™ Coronary Imaging CatheterBoston ScientificNo
(Recalled on March 28 2011)
Intravascular Ultrasound (VH-IVUS) with Virtual HistologyVH® IVUS Imaging SystemVolcano CorporationYesAug 18 2005
Volcano imaging system with a 20-MHz Eagle Eye Gold IVUS imaging catheterVolcano Therapeutics Inc, Rancho Cordova, CalifYesAug 18 2005
Optical Coherent Tomography (OCT)C7-XR™ OCT Intravascular Imaging SystemLightLab Imaging Inc./St. Jude MedicalYesApr 30 2010
C7 Dragonfly™ Intravascular Imaging CatheterSt. Jude medicalYesApr 30 2010
Near-Infrared Spectroscopy (NIR)LipiScanInfraReDx, IncYesApril 25 2008
NIR spectrometer model 6500FOSS NIRSystems, Inc.No
AngioscopyA5000Applied Medical Resources CorporationYesJuly 11 1995
Intravascular Magnetic Resonance Imaging (MRI)Cathamaran™ IVMRI SystemTopSpin Medical Inc.No
ElastrographyGalaxy IVUS scannersBoston ScientificYesApril 22 1998
LOGIQ E9 ultrasound platformGE HealthcareYesAugust 15 2008
Atlantis® SR Pro Imaging CatheterBoston ScientificYesNov 30 2006
ThermographyEpiphany Coronary Thermography CathetersRontisNo

From: Appendix D, Description of Intravascular Diagnostic Techniques

Cover of Intravascular Diagnostic Procedures and Imaging Techniques Versus Angiography Alone in Coronary Artery Stenting: Comparative Effectiveness Review
Intravascular Diagnostic Procedures and Imaging Techniques Versus Angiography Alone in Coronary Artery Stenting: Comparative Effectiveness Review [Internet].
Comparative Effectiveness Reviews, No. 104.
Raman G, Yu W, Ip S, et al.

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