THE PILLCAM™ JOURNEY
SIMON TURNERPRODUCT MANAGER - GIHMINIMALLY INVASIVE THERAPIES GROUP
GUIDED BY OUR MISSIONA SHARED SENSE OF PURPOSE
TENET 6To maintain good citizenship as a company.
TENET 1To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.
TENET 5To recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company’s success.
TENET 2To direct our growth in the areas of biomedical engineering where we display maximum strength and ability; to gather people and facilities that tend to augment these areas; to continuously build on these areas through education and knowledge assimilation; to avoid participation in areas where we cannot make unique and worthy contributions.
TENET 3To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.
TENET 4To make a fair profit on current operations to meet our obligations, sustain our growth, and reach our goals.
INVENTION
3
GABBI IDDAN
“I had been involved in military work based on optics, and after speaking with an Israeli doctor named Eitan Skapa, who described the challenges in using traditional endoscopies, I realized that the optics work I was doing could provide an alternative solution,” said Iddan. He started working on the idea as a side project in Israel Military Industries, where he was employed, but eventually the project got too big for IMI’s labs – and Iddan struck out on his own, with Given Imaging established in 1997.
It was really a matter of “shrinking” the missiles that Iddan was working with to the size of a small, ingestible pill with a camera attached – a technology he began working on in the 1980s, but was not really technically feasible until the late 1990s, when miniaturized cameras and transmitters (to send the image viewed by the camera to a nearby computer) became economically and technically feasible. Iddan was able to perfect the first version of the Pillcam in 2000, and in 2001 the device received FDA approval. The rest, Iddan said, is history.
4
CAPSULE ENDOSCOPY MILESTONES
founded
19
98
PillCam ESO 2
20
08
PillCam SB 2
20
04
M2A capsule
re-branded
PillCam® ESO
20
01
M2A capsule
Patency System
20
06
20
09
20
10
PillCam C2
PillCam Colon
20
11
PillCam SB
paediatric
2yrs and up
PillCam
Patients
PillCam SB3
20
15
PillCam UGI
20
18
20
13 PillCam
Crohn’s
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PILLCAM SB CAPSULE EVOLUTION
PillCam SB
– 11 mm x 26 mm
– 1 camera
– 2 frames per second
– Std optics / 1 lens
– 256 x 256 frame
resolution
– Std lighting control
– Std angle of view
140°
– Depth of field 0-30
mm
PillCam SB 2
– 11 mm x 26 mm
– 1 camera
– 2 frames per second
– New optics / 3 lens
– 256 x 256 frame
resolution
– Advanced Automatic
Light Control
– Angle of view 156°
– Depth of field 0-30 mm
PillCam SB 3
– 11 mm x 26 mm
– 1 camera
– Adaptive Frame Rate 2
or 6 frames per sec
– Bidirectional
communications
– 3 lens optical design
– 320 x 320 frame
resolution
– Angle of view 156°
– Depth of field 0-30 mm
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CAPSULE COMPARISON IN VITRO
0mm 2mm 5mm
PILLCAM™SOFTWAREEVOLUTION
9
PILLCAM SOFTWARE EVOLUTION
2001 RAPID 1.3Automatic Viewing Mode
Variable Viewing Speed
2002 RAPID 1.4 Suspected Blood Indicator (SBI)
2003 RAPID 2Patient De-identification
DoubleView
2004 RAPID 3
My GI Dictionary
QuadView
QuickView
2005 RAPID 4RAPID Atlas
Circumference Scale
2007 RAPID 5
New Image Shape - Increased
AOV
Lewis Score
2008 RAPID 5.2
Image Adjustment (IA)
Study Manager
Network Connectivity
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PILLCAM SOFTWARE EVOLUTION
2009 RAPID 6
Progress Indicator
DR3, SB Sensor Belt Support
FICE
Mosaic view
2010 RAPID 7
Polyp Size Estimate
Spellchecker
Electronic Signature on report
WIN 7/64 bit support
2013 RAPID 8
New UI - homepage, ribbon
Supports SB3 (SB3\DR3\AFR)
Enhanced algorithms (reading
time)
Improved Progress Indicator
Complementary QuickView mode
Suggested Landmarks for SB3
2015 RAPID 8.3Reporting Improvements
Dynamic Player Control
KEY NEW FEATURESNEW LOOK AND FEEL
Home Screen Study Manager
New Ribbon panel
New icons
PillCam
SW
Double click to
launch the SW
PillCam
Video
Double click to
open a
PillCam Video
PillCam Documents
Double click to
open the
PillCam
Documents
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PILLCAM™ SOFTWARE V9.0KEY NEW FEATURES
Supports the new PillCam™ Crohn’s capsule
Novel workflow for evaluating and monitoring Crohn’s disease in the small
bowel and colon
Top100 feature which displays the 100 most clinically relevant images that may
include abnormalities
New schematic GI Map showing the capsule location and progress
Addition of hundreds of high-quality images from PillCam™ SB 3 and PillCam™
COLON 2 to the Atlas
Enhanced, modern user interface with intuitive design (colors, icons, flat buttons)
Color-bar image preview that may assist with landmarking for PillCam™ SB
and PillCam™ Crohn’s videos
Support for Microsoft Windows® 10 OS
Support for Ultra HD (4K) monitors (no 96 DPI limitation)
Installation available using a CD or a USB Flash drive and website download
capabilities for the PillCam™ Reader SW
12
KEY NEW FEATURESTOP 100
Top 100: Provides a preview of the 100 most clinically relevant images, likely to
include ulcerations, bleeding, angioectasias, or polyps, depending the capsule type
(PillCam™ SB, COLON and Crohn’s), presented as a video or in page view.
Note
For PillCam™ SB 3 videos the Top 100
feature replaces the SBI functionality and
shows suspected bleeding images
For PillCam™ COLON videos, the Top 100
feature includes suspected polyp and
bleeding images
For PillCam™ Crohn’s videos, the Top 100
feature includes suspected inflammatory
pathologies, bleeding and polyp images
Only available for videos compiled using
PillCam™ Software v9.0
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KEY NEW FEATURESGI MAP PROGRESS INDICATOR
GI MapThe estimated position and the percentage of the small bowel viewed are calculated based
on:
1. Marking the landmarks of the first duodenal image and the first caecal image
2. Advanced algorithms, which estimate capsule speed
3. Passage time
The SB progress percentage is only available for PillCamTM SB videos, however progress
information available for PillCamTM COLON and PillCamTM Crohn’s studies.
SB percentage
viewed
Estimation of
capsule speedProgress
indicator
Passage
time
SB percentage
viewed
New GI Map Old Progress Indicator
14
KEY NEW FEATURES EXTENDED ATLAS LIBRARY
Ulcer Bleeding
PillCam SB3
Normal Polyp
PillCam Colon2
New high-quality PillCam™ images for a larger library of pathologies to improve diagnostic confidence
15
KEY NEW FEATURESTIME BAR PREVIEW IMAGE
Hovering the mouse over the time bar provides an image display of the
thumbnail at that specific location with the time stamp
Preview image
Time bar
Tip
Using Preview image may aid in landmarking
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PILLCAMTM SOFTWARE V9.0COMPARISON WITH PREVIOUS VERSIONS
PillCam SW v9.0 RAPID v8.0
PillCam Crohn’s + -
PillCam UGI + -
SB Video Length 30% shorter vs. 8.0 -
Colon Video Length ~45% shorter vs. 8.0 -
SBI
(blood detection tool)
SB2 - SBi
SB3 – Top100SB2, SB3
Top 100 SB3, Colon & Crohn’s -
Localization
GI Map, Suggested
Landmarks, improved Body
Exit & SB-to-Colon
passage detection
GI Spaghetti track,
Suggested Landmarks
Extended Atlas
Library+ -
Data Recorder 3
Firmwarev02B4 v27F
Data Recorder model DR3, DR2C DR3, DR2C
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PILLCAM PATIENT STORY
PILLCAM™CROHN’SINTRODUCTION
PILLCAMTM CROHN’S SYSTEM INTRODUCTION
Key Features:
Efficient Monitoring: The PillCamTM Crohn’s system allows physicians to directly and non-invasively visualise the small bowel and colon in a single procedure
Comprehensive Visualization: Advanced optics and innovative imaging features allow for a thorough evaluation of Crohn’s disease activity and mucosal healing
Patient-Friendly Imaging: The PillCamTM Crohn’s procedure is non-invasive and does not subject the patient to sedation or radiation. It has the potential to reduce the number of exams to make disease management more convenient.
The PillCamTM Crohn’s system was designed to improve physician’s
diagnostic confidence and productivity when managing Crohn’s disease
patients
ADAPTIVE FRAME RATE AND PILLCAMTM CROHN’SFUNCTION
Patient check-in1.
Capsule paired
• Capsule opened
• Paired with
PillCamTM recorder 3
2.
Capsule ingested
• Transmits at 4 fps3.
AFR activated
• Small bowel detection
• Transmits at 4 or 35
fps
4a. Patient completes
instructions from
recorder alerts
• Regimen reminders
4b.
End of procedure
• Capsule passed or
battery expires
(minimum of 10
hours)
5.
PILLCAMTM CROHN’S PATIENT REGIMEN
Begin clear liquid diet
(Approximately 2L of clear liquids should be
consumed throughout the day
7 pm – 9 pm
Ingest 2L of PEG
(ingest over 2 hours)
Continue with clear liquids
7 am – 9 am
Ingest 2L of PEG
(ingest over 2
hours)
10 am
Ingest PillCamTM
SBC
1 hour later
10 mg metoclopramide
At small bowel detection
180 mL oral sulfate solution
added to 300 mL of water
Drink additional 1L of water
(resume clear liquids)
3 hours later
90 mL oral sulfate solution
added to 150 mL of water
Drink additional 1L of water
2 hours later – 10 mg bisacodyl
suppository
2 hours later – Light mealNot required for all patients
Day 1 Prior Day of Procedure
PILLCAMTM CROHN’SLESION SEVERITY
Mild - 1 Moderate- 2 Severe - 3 Stricture- S
Lesion Severity Rating1. Mild: superficial, small ulcer or erosion
2. Moderate: Intermediate ulcer in terms of size and depth
3. Severe: Prominent ulcer (size & depth) with either circular, longitudinal, “kissing”,
fissuring or “cobblestone” morphology
S Stricture: Existence of a stricture
23
PILLCAMTM CROHN’SULCER SIZE ESTIMATION
Ulcer Size Estimation (USE)
Ruler consisting of two orthogonal lines measuring a constant 5 mm length to estimate the
size of ulcers
The ruler adjusts visually based on the capsule’s depth of view
Accessible from the View screen or the Edit Thumbnail box
Available for PillCam™ Crohn’s studies only
Not to be used to measure any pathology other than ulcers
Note
The Ulcer Size Estimation is a tool for research purposes only and the values
displayed should not be used in making diagnostic or treatment decisions.
The size of the ruler lines change
visually based on the capsule’s
depth of view, however the ruler
measures a constant 5mm length
USE
24
PILLCAMTM CROHN’SVIEW SCREEN - DISEASE EVALUATIONSEVERITY RULER
Prepar
e
View Report
Play the video to evaluate the disease.
When you see a finding that you want to rate , click on
the video image to see the Severity Ruler:
Rate the Severity as follow:1. Mild: superficial, small ulcer or erosion
2. Moderate: Intermediate ulcer in terms of size and
depth
3. Severe: Prominent ulcer (size & depth) with either
circular, longitudinal, “kissing”, fissuring or
“cobblestone” morphology
S Stricture: Existence of a stricture
Move the mouse over the options to see a description
and click Show examples to open the Severity Grade
Examples atlas:
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PILLCAMTM CROHN’SDISEASE EVALUATION METHODOLOGY
30-60%
MCL-1MSL-
2
1/3 SBColo
n1/3 SB1/3 SB
Disease Evaluation
Lesion Severity, Most Severe Lesion (Grade 1-3,
Stricture)
Most Common Lesion
Extent
40%
Disease
Extent
Most
Common
Lesion
(MCL)
Most
Severe
Lesion
(MSL)
Repeat evaluation sequentially for all 3 small bowel segments and the
colon
1 View a segment.
2Grade lesions with
escalating severity
3Evaluate most
common lesion
severity and extent
of the disease in the
segment.
The most severe
lesion is
automatically
included
4
26
PILLCAMTM CROHN’SVIEW SCREEN - DISEASE EVALUATIONGI TABLE AND GI MAP
Prepar
e
View Report
Disease assessment results are automatically populated in the GI Table and GI
Map. Assessment can be modified manually from the GI table at any time.
The GI Map is automatically synchronized with the GI Table
MCL
MSL
The SB is divided
to 3 segments.
Assessment is
performed
separately for
each segment.
Manually evaluate
the involvement of
disease in the
Duodenum,
terminal ileum,
right and left colon
sub-segments
Stricture
Duodenum
TI
SB I
Relevant images are
available by a click
Most
Common
Lesion
Disease
Extent
Most
Severe
Lesion
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PILLCAMTM CROHN’SVIEW SCREEN - DISEASE EVALUATIONCOMPARE PRIOR VIDEO & FINDINGS
Prepar
e
View Report
If a prior Study is available use the Prior Video or Compare Findings tools:
Review a prior video in
a “Read Only” mode
Click View to return
to current study
Compare current findings to prior
findings and evaluate treatment
Complete the Review and continue to generate the Report.
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PILLCAMTM CROHN’SREPORT SCREEN - COMPARE REPORT
Prepar
e
View Report
Click Compare
Report to view
prior report
summary
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Hardware
Software
Capsule
EVOLUTION OF PILLCAM CAPSULE ENDSCOPY
THANK YOU