Visualize the bile duct with clarity

Advancing therapeutic
options in HPB*
stone management

*Hepato-pancreato-biliary

Healthcare Professionals / Gastroenterology / HPB Portfolio / Practical SolutionsTherapy  / Stone management

Challenges in biliary
stone management 

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The effective management and treatment of bile duct stones can often be challenging.1

The patient’s clinical condition, the characteristics of the biliary stone(s), and a host of anatomical variables may all contribute towards the technical difficulty of endoscopic stone clearance.2

Boston Scientific’s comprehensive product portfolio can help you navigate the different clinical scenarios in stone management. Achieving stone clearance in cases across the spectrum of complexity is made possible with our suite of advanced, reliable, and effective technologies.

Enabling efficient and effective treatment procedures

At Boston Scientific, we work tirelessly to deliver innovative solutions that help you offer the best possible patient experience. 

Stone retrieval with extraction balloons

Extract with precision using our balloon catheters to achieve stone clearance.

Extract with efficiency and control

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Balloon catheters designed for
efficient stone removal

The Extractor™ Pro RX and RX-S are retrieval balloon catheters used endoscopically for the removal of biliary or pancreatic stones and to facilitate the injection of a contrast medium while occluding the duct.

The squared shoulder design and the ability to inflate to two distinct sizes without the need to exchange devices allows you to extract stones efficiently.

The Extractor™ Pro RX-S also features an enhanced design with increased catheter stiffness, providing improved pushability and kink resistance. 

View product information:

Extractor™ Pro Retrieval Balloon Catheters 

The squared shoulder design, reliability, optimal injection flow rates and multiple sizes help facilitate effective and efficient stone removal.


Dilatation-assisted stone extraction

Dilatate with control to remove difficult common bile duct stones.

Dilatate with control and efficiency

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A catheter designed for consistent performance in dilatation-assisted stone extraction

ESGE recommends performing a limited sphincterotomy combined with endoscopic papillary large-balloon dilation as the first-line approach to remove difficult common bile duct stones.3

The CRE™ RX Biliary Balloon Dilatation Catheter is indicated for use in adults for the endoscopic dilatation of the sphincter of Oddi with or without prior sphincterotomy and is available in lengths of 3cm and 5.5cm, with diameters ranging from 6–20mm. Each balloon can be inflated to three distinct and progressively larger diameters, providing flexibility in selecting the most anatomically appropriate approach for difficult stone extraction.

By using the catheter’s injection port, a contrast medium may also be administered for the fluoroscopic visualization of the bile ducts. Radiopaque markers facilitate positioning under fluoroscopy.

View product information:

CRE™ PRO Wireguided and CRE™ RX Biliary Balloon Dilatation Catheter 

CRE™ PRO Wireguided and CRE™ RX Biliary Balloon Dilatation Catheters provide consistent performance for balloon endoscopy for optimal control, efficiency, and performance. Both are indicated for use in the removal of difficult biliary stones (Dilatation Assisted Stone Extraction, DASE).


Mechanical lithotripsy

Use a combined retrieval and mechanical lithotripsy basket to crush large stones with confidence.

Use a combined retrieval and mechanical lithotripsy basket with confidence

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A stone retrieval basket designed to reduce impaction risk

The Trapezoid™ RX Wireguided Retrieval Basket is used to crush and remove biliary stones.

Wire baskets are a well-established method of stone extraction; however, entrapment is a concern associated with this approach.3,4

The Trapezoid™ RX basket has a disengaging tip which reduces the risk of impaction, ensuring the basket can be removed if the stone does not break.

In addition, the Flexi-Stiff™ catheter construction supports the Trapezoid™ RX with a flexible and robust design, built to bend with biliary anatomy while providing maneuverability. The metal alloy basket also maintains its symmetry, even after manipulating difficult stones.  

Download the brochure to learn more about the TrapezoidTM RX Wireguided Retrieval Basket


Electrohydraulic Lithotripsy (EHL) with
direct visualization

Leverage a powerful solution to fragment and clear difficult stones.

Leverage a powerful solution for difficult stones

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Cholangioscopy-assisted lithotripsy is an
effective treatment for difficult bile duct stones

Managing difficult bile duct stones with balloon or basket catheters can be challenging. This may be due to their location (e.g., stones that are intra-hepatic or in the cystic duct), specific stone features, the anatomical characteristics of the biliary tract, or the patient’s clinical needs.1 Cholangioscopy-assisted lithotripsy with electrohydraulic lithotripsy (EHL) or laser system are effective ESGE-recommended therapeutic options for the management of difficult bile duct stones.*1

Results from a recent 2021 meta-analysis evaluating the efficacy and safety of cholangioscopy-assisted lithotripsy contribute to the body of evidence supporting this approach, which showed an overall stone fragmentation success of 95 %, a single session fragmentation and duct clearance of 82% and a rate of 4.6% for the adverse events.2

*Fragmentation of pancreatic stones is an unapproved indication for use of EHL, including the AutolithTM Touch system.

Learn more about the SpyGlassTM DS Direct Visualization System:

SpyGlassTM DS Direct Visualization System

The SpyGlassTM DS system enables direct visualization of the pancreatic and bile ducts. It is used to evaluate suspected benign and malignant conditions and to treat difficult stones and strictures.

The Autolith™ Touch Biliary EHL System is designed for ease of use and efficiency

When conventional stone removal methods are not sufficient to tackle difficult bile duct stones, fragmentation with EHL may be considered as an alternative approach.3 The Autolith™ Touch Biliary EHL System is designed to provide improved patient safety, treatment efficacy, and ease of operation while achieving stone clearance.5 The system is made up of two separate components:

Autolith™ Touch Probe

  • A 375cm-long single use device optimized for use with the SpyGlass™ DS System
  • The direct visualization of difficult stones with the SpyGlass™ DS System may also reduce the need for  repeat procedures by enabling more efficient clinical evaluations6

Autolith™ Touch EHL Generator 

  • The generator provides a precise balance of energy to avoid probe power overload, and monitors the probe to alert the user when it needs to be replaced  
In addition, the SpyGlass™ Retrieval Basket enables the straight forward capture and removal of residual biliary and pancreatic stones and stone fragments. It has also proven efficient to retrieve stones in the intra-hepatic and the cystic duct.7-9

Download the brochure to learn more about
the Autolith™ Touch Biliary EHL System: 

Operate with clarity outside of ERCP

The SpyGlass™ Discover is the only four-way steering single-use digital catheter indicated for use in the pancreaticobiliary system including the hepatic ducts. It represents a comprehensive solution to facilitating stone clearance under direct visualization with alternative approaches, including: 

  • Laparoscopic cholecystectomy with common bile duct exploration (LCBDE; a BSG-recommended solution for common bile duct stone removal in patients undergoing laparoscopic cholecystectomy10)
  • Percutaneous transhepatic cholangioscopy in cases of failed ERCP, altered anatomy, or in patients with peripheral stones11

In both cases, SpyGlass™ Discover can be used with the Autolith™ Touch Biliary EHL System to fragment stones and the SpyGlass™ Retrieval Basket to remove stones or stone fragments.

Learn more about the SpyGlassTM Discover Digital Catheter:

SpyGlass™ Discover Digital Catheter

The SpyGlass™ Discover System was adapted from the latest SpyGlass™ DS II technology, to enable surgeons to perform intra-operative:  

  • Common bile duct (CBD) stone clearance, including trans-cystic lithotripsy, during LCBDE
  • Visual and biopsy-guided mapping of cancer margins during resection of cholangiocarcinoma or main duct intraductal papillary mucinous neoplasms
  • Visualization and therapeutic treatment via percutaneous access

Stenting

Reliable drainage options to provide bile duct patency past a stone.

Drainage solutions for difficult stones

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A trusted biliary stent for difficult situations 

The ESGE recommends endoscopic biliary stent insertion in patients with irretrievable biliary stones that warrant biliary drainage.3 The Advanix™ Biliary Stent is a plastic stent that can be placed when large CBD stones cannot be removed to facilitate bile drainage and provide a short-term solution for alternative stone management approaches.12

Together with the NaviFlex™ RX Delivery System, the Advanix™ Biliary Stent is designed to improve patient outcomes by: 

  • Maximizing flow rate
  • Improving stent deliverability
  • Enhancing procedural control and efficiency through pre-loaded stent and delivery system options

Learn more about the AdvanixTM Biliary Stent

Advanix™ Biliary Stent with NaviFlex™ RX Delivery System

The Advanix™ Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. 


Gallbladder drainage with Lumen
Apposing Metal Stent

A non-surgical treatment option for patients at high risk or unsuitable for surgery.

Alternative treatment options for high-risk patients

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A reliable tool for gallbladder drainage

In most cases, early laparoscopic cholecystectomy is considered the treatment of choice for acute cholecystitis. However, in patients who are elderly, critically ill, or with significant comorbidities, cholecystectomy is considered a high-risk procedure and gallbladder drainage (GBD) is recommended as an alternative treatment.13,14

Of note, the ESGE recommends that in patients at high surgical risk, EUS-guided GBD should be favored over percutaneous gallbladder drainage where both techniques are available, owing to the lower rates of adverse events and need for re-interventions with EUS-GBD.14

The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System is an additional treatment option for patients at high risk or unsuitable for surgery - specifically designed and indicated for the drainage of the biliary tract. An established evidence base has demonstrated its clinical and technical success in creating a new temporary opening between the gallbladder and GI tract for symptomatic cholecystitis patients at high risk or unsuitable for surgery. EUS-GBD using Hot AXIOS™ is a ground-breaking endoscopic option in high-risk surgical patients with acute cholecystitis when performed by an experienced endoscopist.15

The Hot AXIOSTM Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of: 

  • A pancreatic pseudocyst or a walled-off necrosis with ≥70% fluid content
  • The gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery
  • The bile duct after failed ERCP in patients with biliary obstruction due to a malignant stricture

Recommended stent selection method

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NOTE: Ensure there is sufficient space within the target structure to accommodate the Hot AXIOSTM stent flange diameter.
Gallbladder – Select a stent lumen diameter 10 mm or 15 mm based on gallbladder content via EUS imaging.
WARNING: The safety and effectiveness of the 20 mm stent for drainage of the gallbladder and bile duct has not been established.
The stent length (8 mm or 10 mm) is selected to accommodate the combined tissue wall thickness.
Refer to device Instructions for Use for additional Contraindications, Warnings and Precautions.

Learn more about the Hot AXIOSTM Stent:

Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System

The Hot AXIOSTM Stent and Electrocautery-Enhanced Delivery System indicated for use to facilitate transgastric or transduodenal endoscopic drainage of: 

  • a pancreatic pseudocyst or a walled-off necrosis with ≥70% fluid content
  • gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery
  • the bile duct after failed ERCP in patients with biliary obstruction due to a malignant stricture

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