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PillCam ® COLON Capsule

Ø11 mm. 31 mm. PillCam ® COLON Capsule. New PillCam Design 2-sided video cameras; 4 images per second, 2 fps per camera Dimensions: Diameter: Same as PillCam SB Length: 5mm longer than PCSB.

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PillCam ® COLON Capsule

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  1. Ø11 mm 31 mm PillCam® COLON Capsule • New PillCam Design • 2-sided video cameras; 4 images per second, 2 fps per camera • Dimensions: • Diameter: Same as PillCam SB • Length: 5mm longer than PCSB • Optimized optics and automatic light control, with each camera providing more than double the area coverage of PillCam SB • ~10 hours operating time

  2. PillCam® COLON Capsule Sleep Mode • Capsule shuts off 3 minutes post activation to preserve battery energy • Capsule automatically turns back on after 1:45 hours before it enters the colon • European clinical trials with PillCam COLON have been using capsule with 1:45 hours delay mode and Domperidone (e.g. Motililum®)

  3. DataRecorder and RAPID® • SensorArray 8 • 10GB DataRecorder (DR2C) • RAPID5software • Given Workstation

  4. Optional DataRecorder Pouch with Shoulder Strap • Standard pouch with two plastic side loops • Can be used with shoulder strap or standard DR belt • More convenient carry-on method

  5. Sensor Location Guide for PillCam® COLON

  6. RAPID® Real-Time(Real Time Viewer) The procedure utilizes RAPID Real-Time to confirm Capsule exit from the stomach prior to 1st administration of laxative post Capsule ingestion

  7. PillCam® COLON • The colon challenge • The product • Prep and procedure • Potential benefits • Indications

  8. The Colon Challenge • Image the entire colon • Clean the colon • Propel the Capsule

  9. Poor-fair cleansing Good-excellent cleansing Colon Cleansing • Colon cleansing level must be maintained throughout the transit of PillCam COLON up to 8 hours • Colon residue cannot be removed as done during traditional colonoscopy via rinse and vacuum

  10. Standard Colonoscopy prep 60% 20% 10% 10% 20% 90% PillCam® COLON Propulsion • Should be excreted within ~9-10 hours post ingestion • Colon has only ~6 longitudinal contractions per day • Motility stimulants (prokinetic tablets) are required to enhance Capsule propulsion Typical PillCam location at 10 hours post ingestions PillCam COLON prep

  11. Colon Prep and Procedure

  12. PillCam® COLON Prep and Procedure • Traditional colon prepis used until Capsule ingestion • During the ingestion day additional laxatives and prokinetic tablets are provided to the patient • Maintain a clean colon throughout the transit of PillCam in the colon • Enhance Capsule propulsion and excrete it within ~10 hours post ingestion • The specific laxative and prokinetic tablets • Dependent on product availability in each country • Prescribed within their permitted dose

  13. PillCam® COLON Prep and Procedure • As with traditional colonoscopy, it is the responsibility of the physician to prescribe the appropriate PillCam COLON prep and procedure • Given Imaging offers specific prep and procedure regimens for clinical trials only • Given imaging provides the following Patient Instructions for commercial use: • Patients Instruction samples, filled in with information provided in published clinical trials with PillCam COLON • Patient Instructions template to be filled in by the physician (should be based on information provided in published clinical trials with PillCam COLON) PillCam® COLON is not cleared for marketing or available for commercial distribution in the USA [510(k) pending]

  14. Base Line Procedure (Deviere) (1) – Pending capsule exit from stomach (real time viewing)

  15. PillCam® COLON Benefits • Direct visualization of colon mucosa • No sedation • No intubation • No insufflation • No radiation • Potential to improve patient compliance to colon examination and screening

  16. PillCam® COLON Key Messages • PillCam COLON provides a patient-friendly option for visualization of the colon mucosa. • PillCam COLON is complementary to traditional colonoscopy and an appropriate exam for those patients who • have received incomplete colonoscopy • are contraindicated or • are unwilling to undergo traditional colonoscopy

  17. How to read a PillCam COLON video?

  18. Double Head Viewing

  19. Double Head Viewing Click to view green head images only

  20. Green Head Viewing

  21. Green Head Viewing Click to view yellow head images only

  22. Yellow Head Viewing

  23. Yellow Head Viewing Click for double head viewing

  24. Double Head Viewing

  25. Schematic Colon Track Tracing tool allowing convenient and quick identification of the colon section which is currently being viewed • For localization purposes, the colon is schematically divided into 3 segments: • Right (Cecum to Hepatic flexure) • Transverse (Hepatic to Splenic flexures) • Left (Splenic flexure to body exit) • The segment of the colon currently being viewed turns white b a c

  26. Schematic Colon Track Tracing tool allowing convenient and quick identification of the colon section which is currently being viewed • For localization purposes, the colon is schematically divided into 3 segments: • Right (Cecum to Hepatic flexure) • Transverse (Hepatic to Splenic flexures) • Left (Splenic flexure to body exit) • The segment of the colon currently being viewed turns white • The Colon Track is activated after the following anatomical sites are landmarked: • Cecum • Hepatic flexure • Splenic flexure • Body exit b a c Each circle turns yellow after landmarked

  27. PillCam® COLON Images:Spectrum of Colon Disease

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