Boston Scientific SpyGlass DS User manual

You’re going to
want to see this.
™
SpyGlass™DS
Direct Visualisation System

The SpyGlass System Registry* of nearly 300 patients across 15 centers demonstrated:
• Increased sensitivity vs standard ERCP with fluoroscopy-guided biopsy
• Altered clinical management (in 64% of the diagnostic procedures)
• High success rate for removing large or difficult stones (92%)
The SpyGlass DS System allows you to realise the
benefits of cholangiopancreatoscopy as an extension
of the ERCP procedure and new standard of care†.
SpyGlass™DS Direct Visualisation System
†Compared to the first generation SpyGlass Direct Visualisation System
*GIE, October 2011
Does reliance upon two dimensional, black
and white imaging (fluoroscopy) enable
the most effective way to diagnose and
treat pancreaticobiliary strictures and stones?
SpyGlass™DS System image showing
LHD villous lesion in same patient
Fluoroscopy image of
Left Hepatic Duct (LHD) villous lesion

Digital + Simple = DS
Simple
* Vs first generation SpyGlass System
Enhanced Visualisation*
• Digital sensor
with ~4x resolution
• 60% wider field
of view
• Automatic light
control & LED
illumination
• Dedicated irrigation
and aspiration
connections to clear
field of view
Improved Usability*
• Redesigned working channel
for passing accessories
• Dedicated irrigation and aspiration
channels/connections
• Fixed imager for consistent steering
• Single-use digital scope
Digital
Simplified Set-up*
• Set-up time under 5 minutes
• Equipment designed to fit on a
standard endoscopy cart
• Automatic white balance and focus
• Integrated digital sensor - NO fragile
optical probe to load or reprocess
First generation
SpyGlass™System image
SpyGlass DS System image

Accessories
SpyBite™Biopsy Forceps
The SpyBite Biopsy Forceps are intended to be
used with the SpyScope™ DS Access and Delivery
Catheter to enable targeted specimen sampling
under direct visualisation throughout the
pancreaticobiliary system.
Sensitivity
Shown to be more than 1.6 times greater
for targeted biopsies taken under direct
visualisation compared to brushing or
fluoro-guided biopsy alone.1
Specifications
• 1mm outer diameter
• Biopsy cup: 4.1mm opening at 55º
• Central spike in specimen cup aids
in securing samples in difficult anatomy
EHL and Holmium Laser
Both EHL and Holmium Laser may
be used in conjunction with the
SpyGlass™ DS System to manage
large biliary stones.
Northgate Technologies, Inc. (EHL*) and
Lumenis (Laser**) have demonstrated
compatibility with this system.
* Biliary EHL Probe, #9-202-3751, 1.9 Fr, 375cm
** SlimLine GITM Laser Probe, #0644-007-01, 1.8Fr
1. Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the
time of ERCP: a prospective, long-term follow-up study, Peter Draganov et al, GIE, Vol. 75 (2); February 2012.
Taking biopsies under direct visualisation
using miniature SpyBite Forceps
Fragmenting a large biliary stone using a
holmium laser probe with SpyGlass DS System

Clinical Data Highlights
First Generation SpyGlass™System
Since the launch of the SpyGlass Direct Visualisation System in 2007, more than
50,000 procedures have been performed and over 150 articles published – further
documenting its clinical significance as an extension of the ERCP procedure.
26 Patients, Peter Draganov, MD, et al, GIE, Vol. 75(2),
2012
Key Results: Demonstrated 76.5% sensitivity using
SpyBite™ Forceps performing cholangioscopy with
the SpyGlass System vs 29.4% sensitivity using
blind biopsy and 5.9% sensitivity using brushings.
0
10
20
30
40
50
60
70
80
0
10
20
30
40
50
60
70
80
76.5%
29.4%
5.9%
Indeterminate Stricture Diagnosis
108 Patients, Takao Itoi, MD, et al, Digestive Endoscopy, Vol. 22, S1, 2010
Key Results: 24% of patients had residual stones missed on standard
ERCP without cholangioscopy.
64 patients, Amit Maydeo, MD, et al, GIE, Vol. 74(6), 2011
Key Results: Demonstrated 83.3% stone clearance in a single
ERCP session.
Stone Management
297 Patients, 15 Centers, Yang Chen, MD, et al,
GIE, Vol. 74, 2011
Key Results: Clinical management was altered in 64%
of patients undergoing diagnostic procedures during
ERCP using cholangioscopy with the SpyGlass System.
Clinical Registry
64%

All cited trademarks are the property of their respective owners.
CAUTION: Law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can
be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations.
ENDO-321903-A A June 2015. Printed in the The Netherlands by De Budelse/Gosling.
© 2015 Boston Scientific Corporation
or its affiliates. All rights reserved.
DINEND2345EA
www.bostonscientific.eu
Ordering Information
SpyGlass™DS System
Order Number Product Description
M00546650SpyGlass DS Digital Controller
M00546600SpyScope™ DS Access & Delivery Catheter
SpyGlass DS Accessory Devices
Order Number Product Description
Cable
Diameter
Jaw Outer
Diameter
Jaw
Opening
Working
Length
Required Endoscope
Working Channel
M00546270SpyBite™ Biopsy Forceps 0.039"/ 1.0mm 1.0mm 4.1mm / 55° 270cm 1.2mm
M00546451Irrigation Tubing Set (box 10) – – – – –
Early Physician Feedback
“ The enhanced image quality is the most important improvement made to the SpyGlass
DS System. This key feature could potentially help us to detect changes in vascular
patterns and therefore differentiate between inflammatory and neoplastic disease.
Very important also is:
• The quick and easy set-up of the system that makes it possible to use it
mid-procedure without relevant delay
• The single-use design of the SpyScope that makes malfunctions very unlikely
• The overall improved maneuverability that allows deep cannulation into the
intrahepatic ducts even in diffuse biliary disease”
– Dr. Dechene
Universitätsklinikum Essen, Germany
“ With SpyGlass DS the treatment of difficult stones has become faster, safer and more
efficient overall. The improved image quality, the addition of the suction feature and the
overall enhanced stability of the SpyScope will allow us to treat gallstone disease in a
single setting with very high success rates.”
– Dr. Sturgess
Aintree Hospital, Liverpool UK
Contact your local Boston Scientific
representative for more information.