SpyScope™ DS II Indications, Safety, and Warnings
SpyBite™ Single-Use Biopsy Forceps Indications, Safety, and Warnings
SpyGlass™ DS II Digital Controller Indications, Safety, and Warnings
SpyBite Max™ Single-Use Biopsy Forceps Indications, Safety, and Warnings
SpyGlass™ Retrieval Basket Indications, Safety, and Warnings
SpyGlass™ Retrieval Snare Indications, Safety, and Warnings
EXALT™ Model D Single-Use Duodenoscope Indications, Safety, and Warnings
*A real-world data analysis of 5,873 US Medicare patients aged 65 or older having been diagnosed with cholangiocarcinoma (CCA) and who had – in the year prior to CCA diagnosis – only one ERCP, with or without cholangioscopy, between 2015 and 2023 showed reduction in diagnostic time compared to ERCP alone (29.7 days vs. 42.0 days).
**Assumes full conversion to EXALT Model D Single-Use Duodenoscope.
1. Sejpal DV, Trindade AJ, Calvin L, et al. Prospective evaluation of digital peroral cholangioscopy for the detection of residual biliary stones that are missed with conventional ERCP: an interim analysis. Tu1418. Gastrointest Endosc. 2017;85(Suppl):AB618.
2. Bang JY, Sutton B, Hawes R, et al. Concept of disposable duodenoscope: At what cost? Gut. 2019;68(11), 1915–1917.
3. Muthusamy et al. Economic Burden of Emergent Practices of Duodenoscopes Reprocessing and Surveillance: Balancing Risk and Cost Containment. DDW 2018.
4. Ofstead et al. A Glimpse at the True Cost of Reprocessing Endoscopes. Results of a Pilot. Communique. January/February 2017: 63-78.
5. Data on file with Boston Scientific.
6. Bruno MJ, Beyna T, Carr-Locke D, et al. Global prospective case series of ERCPs using a single-use duodenoscope. Endoscopy. 2023;55:1103–1114. Sponsored in part by Boston Scientific.
7. Muthusamy VR, Bruno MJ, Kozarek RA, et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2020;18:2108–2117.e3. Sponsored in part by Boston Scientific.
8. Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. 2021;70:838–844.
9. Napoléon B, Gonzel JM, Grandval P, et al. Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study. Dig Endosc. 2022;34:215–221.
10. Slivka A, Ross AS, Sejpal DV, et al. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021;94:1046–1055.
11. Shahid HM, Bareket R, Tyberg A, et al. Comparing the safety and efficacy of two commercially available single-use duodenoscopes:
A multicenter study. J Clin Gastroenterol. 2023;57:798–803.
12. Persyn D, Van Malenstein H, Vanderschueren E, et al. Performance and applicability of a first-generation single-use duodenoscope:
A single-center cohort study. Ann Gastroenterol. 2022;35:368–375.
13. Based on sales data of all iterations of the SpyScope DS & DS II shipments since 2015. Data on file with Boston Scientific.
Caution: U.S. Federal law restricts these devices to sale by or on the order of a physician.
All photographs taken by Boston Scientific.