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SpyGlass™ DS II Direct Visualization System

featuring Sight Shield Technology

Innovative tools to see, diagnose, and treat

The SpyGlass DS II Direct Visualization System includes an expansive portfolio of devices that deliver innovative diagnostic and therapeutic approaches to biliary stone and stricture management ­– all to help drive successful outcomes in complex endoscopic retrograde cholangiopancreatography (ERCP) cases. These accessories may also help to define pre-surgical mapping and the inspection of tissue before and after ablation procedures.
SpyGlass DS II tool family
 

SpyBite™ Max Biopsy Forceps

Helps enable greater tissue acquisition than Legacy SpyBite5

SpyGlass™ Retrieval Snare

Designed to efficiently capture and remove foreign bodies – such as migrated plastic stents – in the biliary and pancreatic ducts.

SpyGlass™ Retrieval Basket

A durable 4-wire nitinol basket designed to grasp biliary and pancreatic stones while maintaining its shape in a difficult anatomy.
 

SpyGlass DS II System & AUTOLITH® TOUCH Biliary EHL System

The Northgate Technologies, Inc. AUTOLITH® TOUCH unit is a software controlled, electronic device capable of cracking large stones. The objective is to reduce the size of the stones so that fragments can be removed without major surgery. The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies, Inc. bipolar disposable EHL probes for the fragmentation of biliary stones.The AUTOLITH TOUCH Biliary EHL System is distributed by Boston Scientific.

The AUTOLITH TOUCH 1.9Fr., 375cm EHL probe is a single-use device to be used with the AUTOLITH TOUCH Biliary EHL Generator. The EHL probe, when used with the SpyGlass II DS System, helps to manage large biliary stones.

 

Stone Management

The SpyGlass DS II System, combined with the AUTOLITH TOUCH Biliary Electrohydraulic Lithotripsy (EHL) System or other compatible lithotripsy devices, provides the capability to fragment large biliary stones under direct visualization and has demonstrated a high stone clearance success rate in single session treatments.1
  • The ASGE describes difficult stones as those that are: Large (>10 mm), Unusually hard or eccentric in shape, Located in an abnormal distal duct (oblique, narrowed, difficult angulation), or Impacted or present in high multiplicity. These factors can make stones refractory to extraction.
  • The rate of clearance of difficult biliary stones in a single-session ERCP using SpyGlass™ Direct Visualization System has been shown to be greater than 70%.1
  • The SpyGlass™ Retrieval Basket is a durable 4-wire nitinol basket designed to grasp and remove biliary and pancreatic stones and stone fragments while maintaining its shape in a difficult anatomy.
  • Achieving single-session stone clearance and reducing the need for a repeat procedure may deliver greater patient satisfaction and decrease additional procedural costs.8
 
View of biliary stone
Cholangiocarcinoma
 
Fragmenting stone using EHL
Normal_Deep_Left_Hepatic_Duct
Removing a residual stone using the SpyGlass Retrieval Basket
Cystic_Duct_Stone
 

Stricture Management

When used during an ERCP procedure, the SpyGlass DS II Direct Visualization System with Sight Shield Technology enables direct visualization of the bile and pancreatic ducts and can help perform biopsies, diagnose indeterminate strictures, and remove foreign bodies such as migrated biliary and pancreatic plastic stents.
  • Performing biopsies under direct visualization using the SpyGlass DS System and Legacy SpyBite Biopsy Forceps may enable more definitive diagnosis of malignancies through increased sensitivity compared to brush cytology.3, 4
  • SpyBite Max Biopsy Forceps – a design enhancement to the Legacy SpyBite Biopsy Forceps - has been shown to acquire on average more than 2X tissue per bite.5
  • Studies have shown that the SpyGlass™ Direct Visualization System impacted clinical management and diagnostic procedures in more than 85% of patients evaluated.6, 9
  • The SpyGlass Retrieval Snare is designed to efficiently capture and remove foreign bodies – such as migrated plastic stents – in the biliary and pancreatic ducts.
 
Exophytic Vascular Tissue
Cholangiocarcinoma
Cholangiocarcinoma Extension
Normal_Deep_Left_Hepatic_Duct
Cholangiocarcinoma STX
Normal_Deep_Left_Hepatic_Duct
 

Dr. Neil Sharma presents: A Video Series on Indeterminate Biliary Strictures

Pre-procedure Planning and Diagnostic Modality Selection:

Biopsy Collection and Alternative Technique:

Pathology Considerations:

 

Facilitating Ablation Procedures

When used in conjunction with the Habib™ EndoHPB Bipolar Radiofrequency Ablation Catheter and metal stent placement, the SpyGlass DS II System may be a useful tool to help confirm ablation size and location when used before and after the procedure.
 

Presurgical Mapping

A study found that using the SpyGlass™ DS System to map malignant involvement in the biliary or pancreatic ducts before surgery changed the surgical plan in 34% of cases out of 118 patients. Surgery was avoided in 65% of these patients, downstaged in 25%, and upstaged in 10%.7
 

Ordering Information

SpyGlass DS II System Accessory Devices
Order NumberDescriptionCable Diameter (in/mm)Jaw Outer Diameter (mm)Working Length (cm)Required Endoscope Working Channel (mm)
M00546470SpyBite Max Biopsy Forceps0.039 / 1.012861.2
M00546550SpyGlass Retrieval Basket0.039 / 1.0n/a2861.2
M00546560SpyGlass Retrieval Snare0.039 / 1.0n/a2861.2
 
Biliary EHL Probe
Order NumberDescription
M005466201.9 Fr., 375cm Biliary EHL Probe
 
AUTOLITH TOUCH Biliary EHL System & Accessories
Order NumberDescription
M005466800AUTOLITH TOUCH EHL Generator
M00546750AUTOLITH TOUCH Extender Cable
M00546760AUTOLITH TOUCH Foot Pedal
 

Physician Resources

 

1. Brewer Gutierrez OI, et al. Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones. Clin Gastroenterol Hepatol. 2018 Jun;16(6):918-926.e1.

2. ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, et al. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019;89:1075–1105.

3. Shah et al. Performance of a fully disposable, digital, single operator cholangiopancreatoscope. Endoscopy 2017; 49: 651–658.

4. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan;81(1):168-76.

5. Twenty-five physicians acquired samples in a simulated clinical environment with ex-vivo porcine tissue using both Legacy SpyBite and SpyBite Max Biopsy Forceps. Acquired tissue samples were measured and compared. Bench Test results may not necessarily be indicative of clinical performance. The testing was performed by or on behalf of BSC. Data on file.

6. Almadi MA, Itoi T, Moon JH, et al. Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry. Clinical Study. Endoscopy. 2020;52:574–582.

7. Tyberg A, et al. Digital Pancreaticocholangioscopy for Mapping of Pancreaticobiliary Neoplasia: Can We Alter the Surgical Resection Margin? J Clin Gastroenterol. 2019 Jan;53(1):71-75.

8. Deprez PH, Duran RG, Moreels T, Furneri G, Demma F, Verbeke L, et al. The economic impact of using single-operator cholangioscopy for the treatment of difficult bile duct stones and diagnosis of indeterminate bile duct strictures Authors. 2018; 109–118.

9. Maydeo AP, Rerknimitr R, Lau JY, et al. Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates. Endoscopy. 2019;51:922–929.

All photographs taken by Boston Scientific

BSC's Legacy SpyBite Biopsy Forcep device has reached end of life and is not commercially available.

Caution: U.S. Federal law restricts this device 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 or at www.IFU-BSCI.com.

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