options in HPB*
Challenges in biliary
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
Stone retrieval with extraction balloons
Extract with precision using our balloon catheters to achieve stone clearance.
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 for ExtractorTM Pro Retrieval Ballon Catheters:
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.
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 for CRETM PRO Wireguided and CRETM RX Biliary Balloon Dilatation Catheter:
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).
Use a combined retrieval and mechanical lithotripsy basket to crush large stones with conﬁdence.
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
Leverage a powerful solution to fragment and clear diﬃcult stones.
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.
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.
SpyGlass™ Retrieval Basket
- 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.
Explore our solutions for electrohydraulic lithotripsy with direct visualization:
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.
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
Autolith™ Touch Biliary EHL System
The Autolith Touch 1.9Fr., 375cm EHL Probe is a single-use device and is to be used with the Autolith Touch EHL Generator. The EHL probe was optimized for use with the SpyGlass™ DS Direct Visualization System to help manage large biliary stones.
Reliable drainage options to provide bile duct patency past a stone.
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
View product information for AdvanixTM biliary Stent with NaviFlexTM RX Delivery System
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.
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
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.
View product information for Hot AXIOSTM Stent and Electrocautery Enhanced Delivery System:
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