Spyglass® Direct Visualization System

SpyGlass® Direct Visualization System

One System. One Operator. One Solution. Table of Contents

1 SpyGlass® Direct Visualization System Overview

2 SpyScope® Access and Delivery Catheter

4 SpyGlass Direct Visualization Probe

6 SpyBite® Biopsy Forceps

8 SpyGlass Direct Visualization System Capital Components he SpyGlass® Direct Visualization System is an intuitive platform that enables simple, single-operator, direct visualization cholangioscopy for detection and treatment of large Tstones and strictures throughout in the pancreatico-biliary system.

By attaching the single-use SpyScope® Access and Delivery Catheter to a standard duodenoscope and inserting through the working channel, the SpyGlass Direct Visualization System allows for: SpyBite Forceps

• Site-specific examination of the entire lumen, made possible by 4-way deflection and fiber optic lighting and imaging technology.

• Improved diagnosis by visualization and SpyBite® Forceps biopsy, allowing for adequate tissue acquisition for histological examination in 88% of patients.*

• Treatment of large biliary stones by either electrohydraulic lithotripsy (EHL) or Holmium Laser lithotripsy through the 1.2mm working channel, EHL Fiber under direct visualization for focused treatment. Each year more than one million people throughout the world undergo endoscopic retrograde cholangiopancreatography (ERCP) for conditions related to the liver, gallbladder, pancreas and bile ducts.* * The benefits of direct visualization cholangioscopy are well known and documented but traditional approaches limited adoption due to the need for two operators and continual, costly capital scope repairs.

The SpyGlass System addresses both of these limitations with a single-operator,

single-use device that is redefining cholangioscopy with over 30,000 worldwide Laser Fiber cases completed to date.* *

*Meining A, Chen Y, Pleskow D, et al; Direct visualization of indeterminate pancreticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience, Gastrointestinal Endoscopy, November 2011. 1 **Data as of January 2012. ➢ Distal Tip’s 10Fr outer diameter facilitates access to the duct system with 1.2mm accessory channel, optical channel and 2 dedicated irrigation channels.

➢ Dual Controls allow for 4-way deflection to navigate tortuous anatomy.

➢ Locking mechanism ensures direct visualization of target is easily maintained throughout entire procedure.

® 2 SpyScope Access and Delivery Catheter SpyScope® Access and Delivery Catheter

he SpyScope Access and Delivery Catheter Three dedicated ports for: is a single-use, single-operator controlled device designed ➢ Device Delivery: SpyBite® to facilitate access to the pancreatico-biliary anatomy for Biopsy Forceps, EHL or Holmium T Laser probes for large biliary both diagnostic and therapeutic procedures. The SpyScope Catheter stone management. is comprised of a control handle that attaches to any standard ➢ Optics: SpyGlass® Probe for duodenoscope and a long, flexible delivery catheter that is inserted delivery of light and transmission down the working channel of the duodenoscope and passed directly of image. past the ampulla into the pancreatico-biliary anatomy. This design ➢ Irrigation: Flush and aspirate allows for a single physician to simultaneously operate both scopes anatomy to clear the field of view and optimize visualization. for a greatly simplified cholangioscopy procedure.

Handle • Dial knob controls with locking • Dedicated ports for delivery and mechanism facilitate deflection up independent control of optics, to 30° in all four directions for irrigation and SpyBite Forceps or greater control. lithotripsy accessories.

Catheter Device Delivery Port • A 10Fr (3.3mm) outer diameter, • Four-way tip deflection allows for 230cm length catheter fits down enhanced directional control and standard duodenoscope working more precise navigation. channel and allows for easy • 1mm optical channel for SpyGlass access to non-dilated pancreatico- Direct Visualization Probe facilitates biliary anatomy. both illumination and endoscopic • Dedicated 1.2mm accessory channel visualization. for significant biopsy specimen Optic Port • Dual, independent irrigation retrieval with SpyBite Forceps and channels for fluid aspiration to large biliary stone management with maintain visualization. EHL or Holmium Laser lithotripsy.*

SpyScope Access and Delivery Catheter Order Number Description Irrigation Port M00546230 SpyScope Access and Delivery Catheter Recommended Guidewire: 0.035” (0.89mm), 450cm Jagwire® Guidewire or 450cm Hydra Jagwire® Guidewire

*The SpyGlass System has also been shown to be compatible with the Northgate® 1.9Fr Biliary Probe (9-195-25) and the Northgate Autolith® Intracorporeal Electrohydraulic

® Lithotripsy iEHL Generator (9-201-00) for EHL applications. The SpyGlass System has also been shown to be compatible using the Lumenis® SlimLine™ 365 micron Laser probe (M0068408420) and the Lumenis® VersaPulse SpyScope PowerSuite 20 Watt Holmium Laser Generator (M0068408220). The testing followed the laser probe placement instructions. 3 Northgate and Autolith are trademarks of Northgate Technologies, Inc; Lumenis and Slimline are trademarks of Lumenis Ltd. Access and Delivery Catheter SpyGlass® Direct Visualization Probe

he SpyGlass® Direct Visualization Probe is a fiber optic device designed to optimize light delivery to the anatomy T and to acquire and transmit endoscopic images back to the camera. The probe connector on the proximal end attaches to the light guide and ocular. The SpyGlass Probe, when delivered through the SpyGlass Catheter, provides complete circumferential visualization in the pancreatico-biliary anatomy, which may expand options for visual diagnosis and targeted tissue acquisition, potentially leading Probe Connector to accelerated diagnosis and altered patient treatment.

• 6,000 pixel image bundle surrounded by 225 light fibers optimize illumination and image quality in a .9mm diameter probe.

• Outer sheath engineered for maximum flexibility and pushability to facilitate access to any target within the pancreatico-biliary anatomy.

• Distal lens provides 70° field of view to capture complete circumferential visualization within the lumen.

• Durable, re-useable design for up to 20 cases. Optic Port The probe should be reprocessed and stored and protected in the large or small SpyGlass System storage tray.2

SpyGlass Direct Visualization Probe Order Number Description M00546030 SpyGlass Direct Visualization Probe1 M00546040 Ocular M00546050 Probe Small Storage Tray2 M00546060 Probe Large Storage Tray2 M00546210 Light Cable Working Length – 231cm; Field of View – 70°; Maximum Insertion Portion – 0.81mm; Maximum Diameter – 0.9mm; Minimum Required Working Channel – 1mm

4 1Please refer to the SpyGlass Direct Visualization Probe Directions for Use. 2Large Storage Trays are recommended whenever possible to maintain a larger loop radius for the coiled probe, which puts less strain on the probe fibers. ➢ Re-useable fiber optic technology delivering illumination and visualization at 6,000 pixels.

® SpyGlass 5 Direct Visualization Probe ® 6 SpyBite Biopsy Forceps SpyBite® Biopsy Forceps

he SpyBite Biopsy Forceps is designed to be inserted through the accessory channel of the SpyScope® Access and T Delivery Catheter to facilitate site-specific specimen acquisition under direct visualization throughout the pancreatico-biliary system.

• The 1mm outer diameter is designed to fit easily through the SpyScope Catheter working channel, but also allow for 4.1mm jaw opening at 55° for substantial tissue pathology acquisition.

• The central spike in the specimen cup further aids in securing tissue samples in SpyBite Forceps difficult anatomies.

• Has demonstrated to be 88% effective in acquiring sufficient tissue for histological evaluation, significantly better than cytology brushing alone*.

Tissue acquisition in the common bile duct (CBD) using SpyBite Forceps

➢ Biopsy Cup: 4.1mm opening at 55° for maximum tissue acquisition

Breaking a large stone in the CBD using EHL Probe

SpyBite Biopsy Forceps Required Endoscope Order Cable Jaw Outer Jaw Working Working Number Description Diameter Diameter Opening Length Channel M00546270 SpyBite Biopsy Forceps 0.039” 1.0mm 4.1mm, 270cm 1.2mm (1.0mm) 55°

® SpyBite 7 *Meining A, Chen Y, Pleskow D, et al; Direct visualization of indeterminate pancreticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience, Gastrointestinal Endoscopy, November 2011. Biopsy Forceps SpyGlass® Direct Visualization System Capital Components

Camera, Camera Head and Ocular The camera utilizes a ¼ CCD color-image sensor that provides three types of video outputs (RGBs, S-video or composite) to easily integrate into any procedure room. The camera head attaches to the camera control unit by a multi-pin cable connector on the proximal end and the ocular on the distal end. The ocular is an opto-mechanic coupler that facilitates focus and transmission of the image from the SpyGlass Probe.

Light Source and Cable The light source utilizes 300W Xenon light technology and features a simple control wheel to adjust the light output. The light guide is composed of a flexible fiber-optic bundle that attaches to the light source via a Wolf connector port and transmits the light to the SpyGlass Probe.

Irrigation Pump, Tubing and Footswitch The irrigation pump and tubing provide fluid flow to the SpyScope® Access and Delivery Catheter in order to clear the duct of debris and maintain clear visualization. The flow rate is adjustable and continuous flow can be controlled by the footswitch.

Pump Specifications Power 100 - 240 V~, 50/60 Hz, 25 VA Flow Rate 0 - 375 ml / min +/- 20% using SpyGlass Irrigation Tube Set M00546451 (without SpyScope® Access and Delivery Catheter)

SpyGlass Probe Trays The SpyGlass Probe re-processing and storage trays come in large and small sizes, and are designed to protect the probe in between uses and during Cidex® Solution or Cidex OPA Solution for disinfecting.

Large Storage Trays are recommended whenever possible to maintain a larger loop radius for the coiled probe, which puts less strain on the probe fibers.

Monitor High-resolution LCD monitor (1280x1024) is designed to attach to the cart and provide bright, clear images under varying lighting conditions. SpyGlass Direct Visualization System Capital Components

8 Cart (3-Joint Arm and Isolation Transformer) Designed for easy transfer between rooms, the SpyGlass® System cart provides space for all required capital equipment along with two storage drawers to fit SpyGlass System storage trays, an isolation transformer (optional) to manage all electrical demands of the equipment on the cart, and flexible 3-joint arm to hold the camera in place and out of the way (also available separately with bedside attachment). The cart also features a mounting bracket for the LCD monitor and four locking casters for simple transportation and stable positioning within the endoscopy suite.

Inputs Outputs 120 / 240 VAC – 50/60 Hz 120 or 240 VAC (voltage selector switch) Input via an IEC 320 Power entry module 1000 VA Maximum On / off switch 9 Receptacles (IEC 320)

Power Cable Pack The power cable pack includes 5 cables of varying lengths to connect the capital units to the isolation transformer. This ensures electrical isolation and enables simple setup after moving from room to room requiring only the connection of the transformer power cable rather than 5 separate connections.

SpyGlass System Capital Components Order Number Component Dimensions Weight (lbs) Weight (kg) M00546160 Travel Cart1 19.5”W x 48.25”H x 21”D 150 68 M00546120 Video Monitor 17.5”W x 15.8”H x 4.75”D 20 9.06 M00546190 Lightsource 12.6”W x 5.6”H x 9.7”D 13 5.89 M00546100 Camera2 – NTSC 12.6”W x 4”H x 14”D 10 4.53 M00546140 Irrigation Pump with Footswitch 8”W x 5.5”H x 6.5”D 5 2.26 M00546070 3-Joint Arm with Clamp3 31.5”L (extended) 1.61 0.73 M00546040 Ocular <0.5 <0.226 M00546210 Light Cable 5’ Long <1 <0.453 M00546260 Isolation Transformer4 (120V) 12”W x 4.5”H x 8.6”D 23 10.432 M00546250 Power Cable Pack Cables included: 2 – 0.5 meter; 1 – 1.0 meter; 2 – 1.5 meter n/a n/a M00546060 Large Probe Storage Tray5 11”W x 2”H x 8”D 2.5 1.134 M00546050 Small Probe Storage Tray5 7”W x 2”H x 5.5D 1.3 0.589 Note: SpyGlass System, when completely assembled with monitor, has a space footprint of 28”W x 70”H x 26”D (711mm x 1778mm x 660mm). Total weight of the assembled system is 214 lbs (97.01 kg).

1Cart includes a 3-joint arm with connector for ocular, but no table clamp; 2Camera System includes camera controller (box), camera head, and video cables for connection to monitor. US Power cord is included in NTSC version. PAL version does not contain a power cord. For ordering information for PAL version, please contact your local sales representative; 33-Joint Arm (without clamp) is included with the Travel Cart (M00546160). The 3-Joint Arm with Clamp (M00546070) is useful if the account does not want to purchase the Travel Cart as it allows the account to mount the arm to another cart or table; 4For ordering information for 240 V transformer, please contact your local salesperson; 5Large Storage Trays are recommended whenever possible to maintain a larger loop radius for the coiled probe, which puts less strain on the probe fibers. 9 Visit the Boston Scientific Endoscopy Channel by using your Smartphone to scan this code or go to www.YouTube.com/BostonScientificEndo

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 www.bostonscientific.com/endo-resources Ordering Information 1.888.272.1001 SpyGlass, SpyScope and SpyBite are registered trademarks of Boston Scientific Corporation or its affiliates. ©2013 Boston Scientific Corporation All other trademarks are the property of their respective owners. or its affiliates. All rights reserved. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. ENDO-61903-AB April 2013