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.
