C7 XR Basic Service Training May 2009

System History • M2 system was produced from 2004 to 2007 – Maximum pullback speed of 2mm/sec – Field upgradeable to M3(M2x) • Replace ENG1 optical engine to ENG2 optical engine • Replace PIU with PIU2 (except Japan)

• M3 system was produced in 2007 and 2008 – PIU2 (except Japan) – Maximum pullback speed of 3mm/sec – Not upgradeable at this time

• C7XR (formerly M4) – CE mark obtained March/09 • 1st commercial shipment April/09

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR™ Key enabling technology: Frequency-Domain OCT (FD-OCT)

Allows imaging at speeds 10X greater than M2 FD-OCT can be implemented in different ways and is known by different names and acronyms; • Fourier-Domain OCT (FD-OCT) • Swept-source OCT (SS-OCT) • Spectral-Domain OCT (SD-OCT) • Optical Frequency Domain Imaging (OFDI)

…but to the non-technologist, it is simply a high-speed version of OCT

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

Frequency-Domain OCT Imaging: Basic Principles sweep

1260 nm

Reflections at different depths generate interference signals with different frequencies

1360 nm

Fast tunable laser

Fixed reference mirror

Fast Fourier Transform (FFT)

Amplitude Frequency (Depth)

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

Frequency-Domain OCT Imaging: Basic Principles

• Want to know more? – Google “Mach-Zender interferometer” • It’s the heart of the C7XR!

• For more on the Dragonfly™ refer to 13926 Dragonfly™ IFU

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7 Dragonfly™ Imaging Catheter Preparation and Connection

•

Connect catheter hub to DOC 2.0™ • •

•

Twist catheter hub 1/8 turn clockwise The catheter fiber engages automatically (~5sec) System calibration automatic (~10sec)

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

Precise Positioning Enabled by Real-time Scanning

1. 2. 3.

Begin live scanning with C7-XR™ system Locate distal edge of stent by viewing stent struts in live OCT Position distal marker beyond target stent

guide wire reflection

stent struts

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

Imaging Process • Inject 14 ml of regular angiography contrast media (Visipaque 320 if possible) • Pullback is initiated automatically • A 50 mm image in 2.5 seconds • Cross-sectional and full length lateral view

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7-XR OCT Imaging: Basic concept Injection of contrast initiates the acquisition of a rapid OCT image sequence with fast pullback. The recorded images are reviewed in a slow playback loop.

Example (LAD):

Flush @ 3, 3.5 or 4 ml/s Infusion time = ~ 3 or 4s Pullback speed = 20 mm/s

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

50mm vessel segment 2.5 second pullback 12-14 ml flush volume

Dragonfly™ Rx Imaging Catheter

• Rx delivery is fast and easy • Torque-wire based fiber rotation for less artifact • 2.7 F tip (4.4 F proximal) – compatible with 6F guide • 2 distal markers 2cm apart • 135cm working length (same as BSC Atlantis)

Flush port

Optical connector

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

OCT Rx catheter

Platform Comparison

C7-XR

M3

M2

IVUS

Frame rate Frames/sec (fps)

100 fps

20 fps

15.6 fps

30 fps

Pullback speed (nominal/max)

20 mm/sec

1.5/3.0 mm/sec

1.0/2.0 mm/sec

0.5 or 1.0 mm/sec

Lines per frame

500

240

200

256

Lateral sampling (3 mm artery)

19 um

39 um

47 um

225 um

Axial resolution

12 um

15 um

15 um

150 um

Scan diameter (in saline)

10.5 mm

6.8 mm

6.8 mm

12-15 mm

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

M3 vs. C7-XR: Image Quality

M3 OCT

C7-XR OCT

Porcine Coronary Artery

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

Beta Release Feedback Dr Francesco Prati – World’s First Clinical Images with C7XR™ and C7Dragonfly™ • First Reaction:

“Astonishing!”

• The system is very fast. I believe this will encourage interventionalists to use it. In comparison, IVUS is much slower • The image quality is excellent. They are also stable; I saw few sewup artifacts, as compared with time domain technology. This consistency of excellent pull-back is an important achievement that I did not expect. • Penetration is a bit improved and I feel like this feature improves image interpretation of plaque in general. In many cases it was possible to address the plaque burden at the stent margin. • Interpretation of stent strut coverage is significantly improved. All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR vs. M3 • Engine is much smaller with fewer moving parts (no rotating cam) • PC is much larger and is more “industrial” in design – A/D conversion is now done in PC – Hard disk size increased to 650GB

• • • • •

Monitor stand has no storage drawers Printer has been removed DVI-I output added to I/O Panel for external monitor System is much quieter There are no plans to develop an upgrade path from M3

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR vs. M3 • PIU2 is being upgraded to DOC 2.0 (PIU2.1) in phases: – Initial release: • Longer optical connection (via short “tunable” jumper) • Longer electrical connection • Coated housing to reduce EMI • Conformal coating on PCB to reduce potential damage by fluid ingress

– Final version: • Gearing and other mechanical changes to reduce noise/vibration at higher frame rates • Other mechanical improvements to improve reliability • Possible additional changes to limit fluid ingress

• Improved crate design with ramp

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR OCT Application • C7XR released with version C.0 OCT application • Automatic Z-offset adjustment – Provides coarse adjustment of Z-offset

• • • •

Supports DVD writing/reading for the first time Improved DICOM setup tab Improved file management “Zoom Out” function to view larger arteries – “Zoom In” radius can be adjusted – Zooms out to 4.5mm radius

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR OCT Application • C.0.1 OCT application update released Dec/09 via “autoload” CD – Contains bug fixes and some user enhancements •

“Export” and “Delete” function are separated in “Database” tab of

“Setup” menu • “Contrast Only” selection in “Configuration” tab of “Setup” menu • “Diameter” function added to “Measurement” drop-down menu – Takes multiple diameters, determines minimum, maximum and mean diameters – Can only be performed once an area measurement is completed

• C.1 will be next major release (~ 5/10) and will include translated OCT application

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR OCT Application • Supports 3 different pullback trigger methods: – Automatic • Software detects when vessel is cleared and initiates pullback

– Pressure • External pressure transducer is connected in-line with injector or syringe and connected to system • After pressure is detected, pullback initiates following set delay time

– Manual • Operator initiates pullback when sufficient clearing is seen

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR: Power Control • Main Power switch is now located at the bottom rear of cart near the PEM • When Power is ON, system is in “Standby” mode • To turn system fully on, Power button on right side of keyboard is momentarily depressed – This button is the “Power” button normally found on the front of a PC and functions the same • There is no button on the back of the PC

• To turn system off, select “Shutdown” from the OCT application and wait! • When process is complete, system can be unplugged or turned off

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.

C7XR: Password Change • Configuration utility cannot be launched via CD • Each system has a unique password based on “System ID” – Required to change modes

• LLI will supply service passwords for each system • To change operating mode, go to Setup – Select Change Operating Mode – Enter password – Select Show Desktop and/or Manufacturing mode

• Desktop password remains the same: LLIAdmin

All images and data property of LightLab Imaging®, Inc. unless otherwise noted.