PillCam™ SB 3 Capsule Indications

• The PillCam™ SB 3 capsule is intended for visualization of the small bowel mucosa and:
  • May be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
  • May be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
  • May be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
• The PillCam™ SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
• The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

Contraindications

• Contraindications for the PillCam™  SB 3 capsule include:
  • Patients with known or suspected GI obstructions, strictures or fistulas based on the clinical picture or pre-procedure testing and profile.
  • Patients with cardiac pacemakers or other implanted electromedical devices.
  • Patients with dysphagia or other swallowing disorders.

Procedure Risk Information

• The risks of the PillCam™ SB 3 capsule include capsule retention, aspiration, obstruction, perforation, and mucosal injury or bleeding.
• Endoscopic placement may present additional risks.
• Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
• After ingesting the PillCam™ SB 3 capsule, and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created near an MRI device.
• Please refer to the product user manual for detailed information.

• The PillCam™ patency capsule is an accessory to the PillCam™ video capsules and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam™ video capsules in patients with known or suspected strictures.
• The PillCam™ patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system.

Therefore, the PillCam™ patency capsule is intended to be used:

• prior to PillCam™ SB capsule in adults and children from 2 years of age, or
• prior to PillCam™ UGI, COLON, and Crohn’s capsules in adults.

Contraindications

• Contraindications for the PillCam™ patency capsule include:
  • Patients with swallowing disorders.

Procedure Risk Information

• The risks of the PillCam™ patency capsule include capsule retention and aspiration.
• Endoscopic placement may present additional risks.
• Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
• After ingesting the PillCam™ patency capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created near an MRI device.
• Passage of an intact patency capsule does not preclude the presence of an intestinal stricture or other pathology.
• Please refer to the product user manual for detailed information.