Medtronic describes the indications for use, contra indications, and procedure risks for their PillCam SB:
Indications for Use
- The PillCam Platform with PillCam SB capsules is intended for visualization of the small bowel mucosa and:
- 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
- May be used in the visualization and monitoring of lesions that may indicate Crohn’s disease 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
Contraindications
- 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
Procedure Risk Information
- The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation
- 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 refer to the product user manual for detailed information
Medtronic / Given Imaging “PillCam Capsule Endoscopy. User Manual RAPID v8.0”, March 2013