Medtronic PillCam SB Indications, Contraindications and Risks

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