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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
System Overview
System Features
Optical Coherence Tomography (OCT) is an imaging modality that uses
fiber-optic technology. The OPTIS™ Integrated Next uses optical imaging
catheters that emit near-infrared light to produce high-resolution real-time
images.
Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure
(Pd) to aortic pressure (Pa), measured during hyperemia. It provides the
maximal blood flow in the presence of a stenosis as a fraction of the achievable
blood flow that would exist in the hypothetical situation that the stenosis was not
present. Pd / Pa at rest is the ratio of distal coronary arterial pressure to aortic
pressure measured at resting conditions.
Resting Full-Cycle Ratio (RFR) is the ratio of Pd to Pa at a point in the cardiac
cycle where the Pd / Pa ratio is minimal. RFR is designed to be used at rest
and, in contrast to Pd / Pa at rest, is a sub-cycle metric.
The physician may use the FFR, Pd / Pa at rest, and RFR parameters, along
with knowledge of patient history, medical expertise, and clinical judgment, to
determine if therapeutic intervention is indicated.
The OPTIS Integrated Next is built into the catheterization laboratory so that
OCT and Physiology are immediately available without the need to find, connect,
position, and power-on a mobile console. The system allows either the sterile
operator or non-sterile operator to control system functions during image and
Physiology acquisition and review, and to view the OCT and Physiology images
on the main catheterization laboratory monitor boom. In addition, the system
incorporates Angio Co-registration, which allows the user to visualize the position
of OCT image data on angiography images, tightening the linkage between
anatomical assessment with OCT and subsequent therapeutic actions.
CAUTION: Medical personnel who use the OPTIS Integrated Next software
must be aware of the system's limitations. Only operators knowledgeable in
OCT and physiologic procedures can determine if use of the OPTIS Integrated
Next software and OPTIS Integrated Next are appropriate. Be sure to read
Safety Information before operating the OPTIS Integrated Next software for the
first time.
CAUTION: Medical personnel who use the OPTIS Integrated Next must be
aware of the system's limitations. Only medical personnel who are
knowledgeable in OCT and physiologic procedures can determine if use of the
OPTIS Integrated Next is appropriate. Be sure to read Safety Information before
operating the OPTIS Integrated Next for the first time.
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OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
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