Indications and Risks
The PillCam™ Platform with PillCam™ SB capsules 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 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 of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy
The PillCam™ Platform with PillCam™ SB capsules 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
- 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 swallowing disorders
- The risks of PillCam™ capsule endoscopy include capsule retention, aspiration or skin irritation. 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™ SB 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 consult your physician for further information.
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