SpyGlass™

Direct Visualization System

History of Cholangioscopy SpyGlass System Timeline Select Clinical References Resources

Development of the SpyGlass™ SystemHistory of Cholangioscopy

1 Chen Y et al, Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc 2011;74:805-814.

With over 300 articles published to date, it is well documented that direct visualization of the bile ducts by peroral cholangioscopy can be of value in the diagnosis of biliary abnormalities, obtaining biopsy specimens, and guiding stone therapy.1

• First use of peroral cholangioscopy reported in the 1970s

• Adoption significantly hampered over the next 30 years due to technical limitations of ‘mother-baby’ cholangioscopes including:

– Fragility resulting in high repair costs

– Limited steerability

– Poor irrigation capabilities

– Requires 2 operators

SpyGlass™ Direct Visualization System

The SpyGlass System was developed to:

• Overcome the limitations of traditional cholangioscopes

• Provide optically-guided therapeutics for targeted stricture and stone management

FIRST single-operator cholangioscopy (SOC) system:

• 10Fr SpyScope™ Access & Delivery Catheter with:

– Two dedicated irrigation channels– Optic channel– 1.2mm diameter therapeutic channel– 4-way tip deflection to facilitate steerability

through small ducts

Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing...

Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing...

Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing...

Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing...

Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is continuing... Innovation is

continuing... Innovation is continuing... Innovation is continuing...

SpyGlass™ System Timeline

1st Documented use of

‘mother-baby’ cholangioscope

1970s

SpyGlass System Launched

2007

1 Preclinical characteristics of the SpyGlass peroral cholangiopancreatoscopy system for direct access, visualization and biopsy, Yang Chen, MD. GIE, Vol. 65, No. 2: 2007.

2 Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos), Yang Chen et al. GIE, Vol 74, Issue 4, October 2011.

*Asia, Middle East and Africa

Slow adoption due to

technical and cost limitations

510(k) Pancreatoscopy

Indication

2009 2011

Clinical Registry in GIE - 297 patients -

largest study of peroral

cholangioscopy2

25,000 cases

60+ publications

600 systems

2014

AMEA* clinical registry:

Targeting 25 sites, 500 patients, 12 countries

50,000 cases

150+ publications

1,000 systems

Pre-clinical study published

GIE1

Innovation is continuing...

Pre-Clinical & Clinical Registry Results

Journal Article Authors Study Type Publication Key Data

1 Pre-clinical characterization of the SpyGlass™ peroral cholangiopancreatoscopy system for direct access, visualization and biopsy

Yang Chen et al

Lab simulation & observational investigation, single user

GIE, Vol. 65, No. 2: February 2007

The SpyGlass System allows access and biopsy targeting

2 Peroral Cholangioscopy (POC) Using a Disposable Steerable Single Operator Catheter for Biliary Stone Therapy and Assessment of Indeterminate Strictures - A Multi-Center Experience Using SpyGlass

Yang Chen et al

Abstract DDW® 2008 Abstract

Peroral Cholangioscopy (POC) identified stones missed by ERCP in 29% pts.

3 Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos)

Yang Chen et al

Prospective clinical cohort study

GIE, Vol. 74, Issue 4, October 2011

• 297 patients • 64% altered patient management • 92% stone success • 66% sensitivity

Evaluation of Clinical Utility of SpyGlass System

4 Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system.

Peter Draganov et al

Prospective cohort study GIE, Vol. 73, Issue 5, May 2011

• 75 patients• 14.2 min mean SpyGlass System

visualization time• 5 min mean setup time

Select Clinical References 1 of 2

Select Clinical References

Indeterminate Stricture Diagnosis

Journal Article Authors Study Type Publication Key Data

5 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

Prospective, long-term follow-up, paired design cohort study

GIE, Vol. 75 (2); February 2012

• 26 patients • 76.5% sensitivity SpyBite™ Forceps vs. 29.4%

blind biopsy & 5.9% brushings

6 SpyGlass™ single-operator peroral cholangioscopy in the evaluation of indeterminate biliary lesions: a single-center, prospective, cohort study

Raffaele Manta et al

Single-center, prospective, cohort study

Surgical Endoscopy, 2013: 27

• 52 patients • 88% sensitivity

7 Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study

Mohan Ramchandani et al

Prospective, single-arm, single-center study

GIE, Vol. 79 (6), June 2014

• 36 patients • 95% cholangioscopic impression

for malignancy• 82% SpyBite Forceps differentiating intent-to-treat

Stone Management

8 Evaluation of Residual Bile Duct Stones by Peroral Cholangioscopy in Comparison with Balloon Cholangioscopy

Takao Itoi et al Retrospective Digestive Endoscopy, Vol. 22, S1, June 2010

• 108 patients• 24% residual stones missed on standard ERCP• Risk factors: large bile duct, juxtapapillary

diverticulum, use of ML or EHL

9 Single-operator cholangioscopy-guided laser lithotripsy in patients with difficult biliary and pancreatic ductal stones (with videos)

Amit Maydeo et al

Prospective GIE, Vol. 74(6), December 2011

• 64 patients• 83.3% single session clearance• Inclusion criteria: Difficult bile duct stones not

amenable to treatment by mechanical lithotripsy and/or balloon sphincteroplasty.

10 Single-operator cholangioscopy for the extraction of cystic duct stones (with video)

Paul Sepe et al Retrospective GIE, Vol. 75(1), January 2012

• 13 patients• 76.9% complete clearance• Inclusion criteria: Cystic duct stones

2 of 2

SpyGlass™ System Brochure ENDO-61903-AB

SpyGlass System Clinical Registry Results Brochure ENDO-61904-AB

SpyGlass System Clinical Registry iFolio ENDO-99801-AA

Resources

One System. One Operator. One Solution.

SpyGlass ®Direct Visualization System

† Deceased

Lead authors Yang K. Chen, MD† Mansour A. Parsi, MD

Douglas Pleskow, MD

FinAl Results FRoM lARgest PRosPeCtive investigAtion

oF PeRoRAl CholAngiosCoPY

Published in Gastrointestinal Endoscopy (GIE)

october 2011

SpyGlass® Direct Visualization System

SpyGlass System Pancreatico-biliary Atlas SME15390

SpyGlass ®D I R E C T V I S U A L I Z A T I O N S Y S T E M

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SME15390 2.5M February 2010

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CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

P A N C R E A T I C O - B I L I A R Y I M A G E A T L A S

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Images courtesy of:Dr. Douglas Adler, University of Utah School of Medicine, UT

Dr. Urban Arnelo, Karolinska University Hospital, Stockholm, Sweden

Dr. Markus Goldschmiedt, Medical Center of Plano, TX

Dr. Bora Gumastop, St. Peter's Hospital, NY

Dr. Kadirawelpillai Iswara, Maimonides Hospital, NY

Dr. Syed Faisal Jafri, Menorah Medical Center, MO

Dr. Pankaj J. Patel, Florida Hospital Heartland Division, FL

Dr. Sandeep Patel, University of Texas Health & Sciences Center, TX

Dr. Ed Schafer, The Nebraska Medical Center, NE

Dr. Adam Slivka, University of Pittsburgh Medical Center, PA

A difference you can see.™

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©2015 Boston Scientific Corporation or its affiliates. All rights reserved.

ENDO290504-AA January 2015

Results from case studies are not predictive of results in other cases. Results in other cases may vary.

Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device.

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Information for the use only in countries with applicable health authority product registrations.

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