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