The document discusses new features of the ILUMIEN OPTIS integrated system, including: 1) A new DOC that allows for increased pullback speed and control from the procedure table. 2) An updated motor and PC with increased processing power, allowing for longer pullbacks at higher speeds and 3D reconstruction. 3) New software that provides automatic measurements, the ability to choose between pullback modes, and co-registration of angiography with OCT images to improve workflow. The system aims to strengthen the link between physiological and anatomical assessment during PCI procedures by providing control and tools for FFR, OCT, and co-registered imaging from the procedure table.

1. OPTIS™
Integrated System
Felipe Hernández
Hospital 12 de Octubre, Madrid

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ILUMIEN OPTIS - Nuevos componentes
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Nueva DOC – Me permite el control desde la
mesa para iniciar el pullback, posibilidad de
rotar a mayor velocidad
2
Nuevo motor (C8) – Trabaja a mayor velocidad,
lo que me permite pullbacks más largos a mayor
velocidad
3 Nuevo PC – Capacidad para 3D
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Nueva tarjeta DAS– Permite almacenamiento y
adquisición de datos de mayor velocidad
5 Dragonfly Duo Imaging Catheter
6 New Software – E.0.2
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ILUMIEN OPTIS
 Reconstrucción real 3D
 Medidas automáticas de Area, MLA. %DS, %AS
 Posibilidad de escoger entre dos pullback:
 75mm pullback
 54mm alta resolución
 FFR con Aeris
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Comparación con ILUMIEN
ILUMIEN ILUMIEN OPTIS
Parameter Nominal
Settings
Long
Pullback
High-resolution
Pullback
Engine speed 100 frames/sec 180 frames/sec 180 frames/sec
Pullback speed 20 mm/sec 36 mm/sec 18 mm/sec
Frame density 5 frames/mm 5 frames/mm 10 frames/mm
Pullback length 54 mm 75 mm 54 mm
Pullback time 2.7 sec 2.1 sec 3.0 sec
Contrast (Max) 14 ml at 4 ml/sec 14 ml at 4 ml/sec 14 ml at 4 ml/sec
File size 271 frames
270 MB
375 frames
375 MB
540 frames
540 MB
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Disponibilidad de varios Pullback
Tenemos disponibles 2 TIPOS DE PULLBACK:
Modo “Survey”:
 Pullback de 75 mm
 Velocidad de 36mm/sg
 Mismo nº de imágenes por mm que ILUMIEN (5 fotos/mm)
 Misma recomendación de uso de contraste que con ILUMIEN
( 4 ml/sec en bolo de 14 ml)
Modo “High-resolution”
 Pullback de 54 mm
 Velocidad de 18mm/sg
 Doble nº de imágenes por mm (10 fotos/mm)
 Misma recomendación de uso de contraste
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OPTIS™ Integrated System
Product Goals
 Strengthen the link between physiological (FFR) and anatomical
(OCT and angio) assessment and subsequent therapeutic action.
 Provide the physician with increased control.
 Continue to improve technology ease-of-use and procedural workflow.
 Make FFR and OCT an integral part of the cath lab.
Clinical Benefits
 Immediate availability during PCI procedure
 Full FFR/OCT system control from tableside
 Rapid set-up without making cable connections
 Direct tableside control of acquisition and
analysis by physician
 Enables real-time angio co-registration
with OCT
 Data displayed on boom monitor
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OPTIS™ Integrated System Architecture
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System Cabinet
Wi-Box™ Unit
DOC and DOC Holster

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Tableside Controller
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Navigation Controller
Rail Clamp
Advanced Display Full Screen (View Mode)
Measurements
Distal Marker Proximal Marker
Lumen Profile
Select Button
Wireless Connectivity Indicator
Blue = Connected Yellow = Not Connected

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Tableside Controller
The Tableside Controller may be used to position the mouse
cursor by tilting the Navigation Controller to the left, right, up,
down or variations thereof.
 The Select button (on the top of the
Navigation Controller) functions as
the left mouse button.
 A twist of the Navigation Controller
functions as the mouse scroll wheel;
twist counter-clockwise to scroll up
or left, and twist clockwise to
scroll down or right.
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DOC Holster
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Rail Clamp
Front View Side View
Dust Cover
Cable Connections

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DOC Controller
The DOC functions have not changed from the
ILUMIEN™ OPTIS™ system.
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Stop – Press to end catheter
motion and laser output.
Enable – Press to Auto
Calibrate, Enable recording
(if calibration is complete),
or Start Pullback when using
Manual Trigger.
Live View – Press to
switch between Standby
View and Live View.
Unload – Press to unload catheter.
Note: The Unload button will not work during a broken
catheter Safe Unload workflow until all the prior steps
have been acknowledged via Accept. See the E.1.1
training module for the workflow steps.
Pullback Motion LEDs –
Off when the imaging catheter
is stationary.
Blinks during pullback.

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FFR Workflow With Tableside Controller
An FFR recording can be completed using the Tableside Controller. The Proximal
Marker Button is used for all key FFR workflow steps; the Distal Marker is used
only to Mark points on the recording. Follow the normal FFR workflow and use the
Tableside Controller in the following way:
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Proximal Marker Button:
All key FFR workflow steps
Distal Marker Button:
Mark

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Angio Co-Registration Introduction
Angio co-registration will facilitate the integration of the OCT pullback
into the PCI workflow.
How does it work?
 The software uses the catheter pullback marker bands visible in the angio cine to
create the co-registered images.
Key Benefits
 Facilitates OCT-guided PCI therapy
 Collects all key vessel information for clinical decision making during one angio cine
 Reduces OCT learning curve and time required to assess location of OCT
 Increases confidence in relative position of angiographic and OCT image features
AC-R software will substantially improve workflow efficiencies when
OCT is incorporated into a PCI procedure.
 Possible reduction in contrast utilization and radiation as compared to using
OCT without AC-R.
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Key Tips for OPTIS™ Angio Co-Registration
Success
Good angio acquisition is key for successful OCT angio
co-registration. The following are some key tips:
 X-ray equipment must be stationary throughout the cine. A view
that minimizes occurrences of vessel foreshortening and branch overlapping will
minimize co-registration inaccuracies.
 LAO Caudal view or “spider view” can present challenges for the left
coronary arterial tree, depending on the angle of the image taken,
especially if target area is in the proximal vessels.
 The cine recording must encompass the entire OCT pullback, including the
radiopaque section of the guidewire, all within the field of view.
If you can see the imaging catheter radiopaque marker bands
on the angio, so can the software.
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Angio Co-Registration Pullback Workflow
When in Live Mode:
1. Click on the Acquire Angio button.
2. Select Enable (on the DOC or the screen).
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Angio Co-Registration Pullback Workflow
When in Live Mode:
3. Step and stay on the Cine Pedal.
4. Deliver contrast flush and begin pullback.
5. Step off the Cine Pedal upon completion of the pullback.
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Angio Co-Registration Workflow
The Angio Co-registration workflow provides guidance on how to
co-register an angio image with the OCT pullback.
 Once the angio and pullback have been acquired, start the co-registration process
by single clicking Co-Register in the lower right corner.
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Note: This screen demonstrates
the Co-Registration step with the
catheter connected. When the
catheter is disconnected, the two
buttons switch locations.
On average, the co-registration takes
about 8 seconds.

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Angio Co-Registration Workflow
If angio co-registration was previously completed successfully, the
ability to re-register will be available under Menu.
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Angio Co-Registration Workflow
Follow the steps to complete the co-registration process
Notes:
 It is important to place the points from distal to proximal for the co-registration process to work.
 Avoid placing control points within the aorta.
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If an incorrect vessel path is traced after placing
the proximal point, click the Undo button and
place a new proximal control point.

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Angio Co-Registration Workflow
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Ensure that the enlarged image has a
circle tracking the lens marker
throughout the pullback and the tracing
of the pathway is within the vessel.
Click Accept to finalize or Cancel to start
the co-registration over.

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Angio Co-Registration Workflow
The software will always provide something to review. If it does
not look accurate or if the image has mostly red frames, Cancel
and go through the provided workflow again.
Key Considerations
 Redoing the workflow:
 May provide an improved co-registration if the hint points did not align with the
guidewire or are in the wrong vessel
 Likely will not provide an improved co-registration if:
 The vessel is foreshortened or the vessels overlap
 The angio is a LAO caudal or spider-view image
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Angio Co-Registration Workflow
Once the co-registration is complete, the marker will move with
the cursor on the pullback.
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Quick Zoom is available on the
screen or TableSide Controller.
Co-registered marker band.
This is white in areas where the
software has high confidence.

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Angio Co-Registration Workflow
The marker on the angio will change to red when in areas that
the software has less confidence due to poor visibility of the
marker band.
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Note: Exercise caution when
interpreting angio co-registration
results in the red areas as the
true location may not correspond
to the marker on the image.

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Obtaining an AC-R Pullback From the Patient
Summary Menu
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Pullbacks with AC-R will
have the angio icon.

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