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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 Basket

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

SpyGlass™ Retrieval Snare

Designed to efficiently capture and remove foreignbodies – such as migrated plastic stents – in the biliaryand pancreatic ducts.
 

SpyGlass DS II System & Autolith Touch Biliary EHL System

Boston Scientific and Northgate Technologies, Inc., work together to provide physicians and hospitals with access to the the Autolith Touch Biliary EHL System and accessories. All system components can be obtained directly from Boston Scientific, which provides an efficient ordering process, first-rate customer support and expanded options for stone management.

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

EHL Infographic
 

Stone Management

The SpyGlass DS II System, combined with the Autolith™ Touch Biliary Electrohydraulic Lithotripsy (EHL) System or other lithotripsy devices, provides the capability to fragment large biliary stones under direct visualization and enable a high stone clearance success rate in single session treatments.1
  • Approximately 10-15% of biliary stone cases are considered difficult and cannot be treated effectively using standard ERCP techniques.
  • Direct visualization stone clearance using EHL has been shown to be clinically effective with demonstrated procedural success, with single-session stone clearance rates of 74.5%.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.
 
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 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 enables faster, more accurate diagnosis of malignancies compared to cytology brushing3, 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 bite5.
  • In a clinical study of 289 patients, clinical management was altered in 85% of patients undergoing diagnostic ERCP with cholangioscopy, and the study showed high procedural success and high accuracy in helping to diagnose indeterminate strictures.6
  • 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.*
Cholangiocarcinoma
View of Cholangiocarcinoma
Pre-Ablation
Cholangiocarcinoma
View of Cholangiocarcinoma
Post-Ablation
 

Presurgical Mapping

A clinical study of 118 patients examined the role of digital cholangiopancreatoscopy technology in “mapping” the extent of malignant involvement in the biliary or pancreatic ducts before surgical intervention. The analysis demonstrated that the surgical plan was altered in 34% of cases when using the SpyGlass DS II Direct Visualization System.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 & Patient Resources

 

* The effectiveness of ablation with the Habib EndoHPB Catheter for use in the treatment of pancreatic or biliary cancer or pancreatic or biliary disease (i.e. improved clinical outcomes) has not been established.

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. Parsi et al. Endoscopic management of difficult common bile duct stones. World J Gastroenterol 2013; 19(2): 165-173

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. Ramchandani, Mohan K. et al. Tu1412 Single Operator Cholangioscopy for the Evaluation and Diagnosis of Indeterminate Biliary Strictures - Results From a Large Multi-National Registry. Gastrointestinal Endoscopy, Volume 85, Issue 5, AB615.

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.

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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