Indications

The PillCam™ Crohn’s capsule is intended for visualization of the small bowel and colonic mucosa.

• It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease.
• It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult).
• It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA).

The PillCam™ Crohn’s capsule may be used as a tool in the detection of abnormalities of the small bowel and colon. It is intended for use in adults and children from eight years of age.

Contraindications

The PillCam™ Crohn’s video capsule is contraindicated for use under the following conditions:

• In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
• In patients with cardiac pacemakers or other implanted electromedical devices.
• In patients with swallowing disorders.

Note: The procedure may involve intake of laxatives and prokinetic agents. Refer to the labeling of these agents for their contraindications.

Procedure Risk Information

The risks of the PillCam™ Crohn’s capsule include capsule retention, aspiration, and skin irritation. The risks associated with colon preparation are allergies or other known contraindications to any preparation agents or medications used for the PillCam™ Crohn’s system regimen, according to laxative medication labeling and per physician discretion. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. After ingesting the PillCam™ Crohn’s capsule, and until the capsule 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.