EXALT™ Model D Single-Use Duodenoscope Indications, Safety, and Warnings
SpyBite™ Single-Use Biopsy Forceps Indications, Safety, and Warnings
SpyBite Max™ Single-Use Biopsy Forceps Indications, Safety, and Warnings
SpyGlass™ DS II Digital Controller Indications, Safety, and Warnings
SpyGlass™ Retrieval Basket Indications, Safety, and Warnings
SpyGlass™ Retrieval Snare Indications, Safety, and Warnings
SpyScope™ DS II Indications, Safety, and Warnings
*Assumes full conversion to EXALT Model D Single-Use Duodenoscope.
1. Almadi MA, Itoi T, Moon JH, et al. Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry. Clinical Study. Endoscopy. 2020;52:574–582.
2. Gutierrez OIB, Bekkali NLH, Raijman I, et al. Efficacy and safety of digital single-operator cholangioscopy for difficult biliary stones. Clin Gastroenterol Hepatol. 2018;16:918–926.e1.
3. 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.
4. Data on file with Boston Scientific.
5. Bang et al. Concept of a disposable duodenoscope: at what cost? Gut. 2019.
6. Muthusamy et al. Economic Burden of Emergent Practices of Duodenoscopes Reprocessing and Surveillance: Balancing Risk and Cost Containment. DDW 2018.
7. Ofstead et al. A Glimpse at the True Cost of Reprocessing Endoscopes. Results of a Pilot. Communique. January/February 2017: 63-78.
8. 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.
9. 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.
10. Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. 2021;70:838–844.
11. 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.
12. 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.
13. 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.
14. 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.
Caution: U.S. Federal law restricts these devices to sale by or on the order of a physician.
All photographs taken by Boston Scientific.