Boston Scientific received FDA approval for SpyGlass Discover in May 2020
SpyGlass Discover is a digital catheter that provides a minimally invasive surgical access to the pancreatico-biliary system through a trans-cystic or trans-ductal approach. SpyGlass Discover is intended to provide direct visualization and allows for accessory devices into the pancreatic-billiary system for both diagnostic and therapeutic applications.
The SpyGlass Discover system is comprised of the Discover scope and the SpyGlass Discover Controller. SpyGlass Discover is disposable, single-use, sterile device that provides a consistent, “plug and play” performance which eliminates contamination risk due to improperly reprocessed scopes, eliminates capital burden of re-usuable scopes, and eliminates reprocessing and servicing downtime and costs.
The importance of utilizing disposable scopes has become apparent following an April 12, 2019 FDA issued safety communication. On October 5, 2015, the FDA ordered three manufacturers (Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, Pentax of America) of duodenoscopes to collect samples for the Sampling and Culturing Study. The March 2019 follow-up study demonstrated higher than expected levels of contamination following reprocessing of duodenoscopes. The study noted:
- For low to moderate concern organisms with >100 CFU, updated culturing results continue to indicate a higher-than-expected contamination rate after reprocessing, with up to 3.6% of properly collected samples testing positive.
- For high concern organisms, defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa, updated culturing results appear to show that up to 5.4% of properly collected samples test positive, which is an increase from the 3% contamination rate that was previously reported.1
SpyGlass Discover eliminates such reprocessing and contamination risk through its single-use design.
SpyGlass Discover allows for four-way steering to provide optimal mobility and navigation throughout the biliary system.
|Direction of View||0 Degrees (Forward Viewing)|
|Field of View||120 Degrees|
|Distal Tip Width||10.5 F (3.5 mm)|
|Maximum Insertion Width||10.8 F (3.6 mm)|
|Working Length:||65 cm|
|Minimum Accessory Channel Width||3.6 F (1.2 mm)|
|Minimum Angulation Range||30 Degrees with accessory device in working channel|
The SpyGlass Discover scope provides:
- Complementary metal oxide semiconductor (CMOS) video imaging system
- Integrated dual LED light source. Lighting is designed to reduce light flare and provide an enhanced view down the lumen
- Dual dedicated irrigation channels
- 1.2 mm working channel for accessories and aspiration
- High Dynamic Range (HDR) processing for improved visibility
- The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication. April 12, 2019. https://www.fda.gov/medical-devices/safety-communications/fda-continues-remind-facilities-importance-following-duodenoscope-reprocessing-instructions-fda. Accessed 8/27/20.