An Expanding Suite of Compatible Accessories and Applications
The SpyScopeTM DS II Catheter is compatible with a full suite of diagnostic and therapeutic accessories to enable the management of complex stones and strictures. It may also be a useful tool to help define pre-surgical mapping and to inspect tissue before and after ablation procedures.
Stone Management
The SpyGlass™ DS System combined with a lithotripsy device, such as the Autolith™ Touch System for Electrohydraulic Lithotripsy (EHL), provides the capability to fragment 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.2
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 can be used to capture and remove residual biliary and pancreatic stones and stone fragments visualized with the SpyGlass DS System.
Achieving single session stone clearance and reducing the need for a repeat procedure(s) may deliver greater patient satisfaction and decrease unnecessary procedural costs.
Stricture Management
When used during an ERCP procedure, the SpyGlass DS System 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 SpyBite™ Biopsy Forceps (86% sensitivity)3 may enable faster, more accurate diagnosis of malignancies compared to brush cytology (45% sensitivity)4.
NEW SpyBite Max Biopsy Forceps - a design enhancement to the legacy SpyBite Biopsy Forceps - have been shown to acquire more than 2X tissue in an average bite.5
In a prospective study of 289 patients, diagnostic ERCP with cholangioscopy altered patient management in 85% of patients and had high procedural success and high accuracy in helping to diagnose indeterminate strictures.6
The SpyGlass Retrieval Snare is designed to enable efficient capture and removal of foreign bodies in the biliary and pancreatic ducts, such as migrated plastic stents, during an ERCP procedure.
Facilitating Ablation Procedures
When used in conjunction with the Habib™ EndoHPB Bipolar Radiofrequency Ablation Catheter and metal stent placement, the SpyGlass DS System may be a useful tool to help confirm the ablation size and location when used before and after the procedure.
Presurgical Mapping
A recent study examining the role of digital cholangiopancreatoscopy technology in “mapping” the extent of malignant involvement in the biliary or pancreatic ducts before surgical intervention demonstrated, through an analysis of 118 patients, that the surgical plan was altered in 34% of cases when using direct visualization with the SpyGlass DS System.7
* 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. 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.
ENDO- 1141101 -AA