OPTIS™ Integrated System

Felipe Hernández

Hospital 12 de Octubre, Madrid

SJM-OPS-0914-0003

ILUMIEN OPTIS - Nuevos componentes

1Nueva DOC – Me permite el control desde la mesa para iniciar el pullback, posibilidad de rotar a mayor velocidad

2Nuevo motor (C8) – Trabaja a mayor velocidad, lo que me permite pullbacks más largos a mayor velocidad

3 Nuevo PC – Capacidad para 3D

4 Nueva tarjeta DAS– Permite almacenamiento y adquisición de datos de mayor velocidad

5 Dragonfly Duo Imaging Catheter

6 New Software – E.0.2

1

2

2

3

4

SJM-OPS-0914-0003

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

3

SJM-OPS-0914-0003

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

4

SJM-OPS-0914-0003

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

5

SJM-OPS-0914-0003

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

6

SJM-OPS-0914-0003

OPTIS™ Integrated System Architecture

7

System Cabinet

Wi-Box™ Unit

DOC and DOC Holster

SJM-OPS-0914-0003

Tableside Controller

8

Navigation Controller

Rail Clamp

Advanced Display Full Screen (View Mode)

Measurements

Distal Marker Proximal Marker

Lumen Profile

Select Button

Wireless Connectivity IndicatorBlue = Connected Yellow = Not Connected

SJM-OPS-0914-0003

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.

9

SJM-OPS-0914-0003

DOC Holster

10

Rail Clamp

Front View Side View

Dust Cover

Cable Connections

SJM-OPS-0914-0003

DOC Controller

The DOC functions have not changed from the ILUMIEN™ OPTIS™ system.

11

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.

SJM-OPS-0914-0003

FFR Workflow With Tableside ControllerAn 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:

12

Proximal Marker Button: All key FFR workflow steps

Distal Marker Button:Mark

SJM-OPS-0914-0003

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.

13

SJM-OPS-0914-0003

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.

14

SJM-OPS-0914-0003

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).

15

SJM-OPS-0914-0003

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.

16

SJM-OPS-0914-0003

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.

17

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.

SJM-OPS-0914-0003

Angio Co-Registration Workflow

If angio co-registration was previously completed successfully, the ability to re-register will be available under Menu.

18

SJM-OPS-0914-0003

Angio Co-Registration WorkflowFollow 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.

19

If an incorrect vessel path is traced after placing the proximal point, click the Undo button and place a new proximal control point.

SJM-OPS-0914-0003

Angio Co-Registration Workflow

20

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.

SJM-OPS-0914-0003

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

21

SJM-OPS-0914-0003

Angio Co-Registration Workflow

Once the co-registration is complete, the marker will move with the cursor on the pullback.

22

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.

SJM-OPS-0914-0003

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.

23

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.

SJM-OPS-0914-0003

Obtaining an AC-R Pullback From the Patient Summary Menu

24

Pullbacks with AC-R will have the angio icon.

SJM-OPS-0914-0003