There are two options for OPTIS™ Imaging Systems: the OPTIS™ Integrated System and the OPTIS™ Mobile System. Both are designed to meet your specific cath lab needs for OCT-guided PCI.
OPTIS™ Integrated System is installed in a single cath lab; it's always on and always ready to perform intravascular imaging and coronary physiology.
The OPTIS™ Integrated System is recommended as your go-to system for imaging and physiology needs, and especially for busy cath labs and high PCI volume centers when the availability of OCT and/or coronary physiology is always needed without advanced arrangements.
OPTIS™ Mobile System is a transportable system designed for use in multiple cath labs.
The OPTIS™ Mobile System provides the same functionality as the OPTIS™ Integrated System, but with a mobile system workflow via an easily transportable cart to serve multiple cath labs.
The OPTIS™ Mobile System is recommended for multiple cath labs that require flexibility or for busy cath labs that already have an OPTIS™ Integrated System and need an additional system as a backup.
*RFR is available with AptiVue™ Imaging Software and Ultreon™ 1.0 Software.
OPTIS™ Imaging System IFU. Refer to Instructions For Use (IFU) for additional information.
MAT-2106760 v1.0
Indications The OPTIS™ Software and AptiVue™ E Series Software are intended to be used only with compatible OPTIS™ Imaging Systems.
The OPTIS™ Imaging System with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Contraindications: The OPTIS™ Integrated System and Mobile System with Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.
Warnings:
Precautions:
MAT-2106760 v1.0