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• PillCam ® SB is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age and up.
• The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing fresh blood or red areas.

Contraindications for the PillCam SB include:
• Patients with known or suspected GI obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
• Patients with cardiac pacemakers or other implanted electro-medical devices.
• Patients with swallowing disorders.

• The risks of PillCam capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the
Agile ™ GI patency test 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, the patient should not be near any source of powerful electromagnetic fields such as one created near an MRI device.
• Please refer to the User Manual or www.givenimaging.com for detailed information.

• Capsule endoscopy (CE) is a less invasive technique for evaluating the small intestine for Crohn’s involvement
• Shown to be more sensitive than radiologic and endoscopic procedures for detecting small bowel lesions
Leighton JA et al. Gastrointest Endosc. 2006;63(4):558-565.

• In prospective, blinded evaluations, CE was demonstrated to be superior in its ability to detect small bowel pathology missed on small bowel radiologic studies and computed tomography (CT) radiologic examinations
• Small bowel strictures are considered a contraindication for CE
• Capsule retention reported to occur in up to 13% of patients with known long-term Crohn’s disease
• Patency capsules are available to assess the potential of retention resulting from a stricture
• Small bowel follow-through, CT enterography, or magnetic resonance (MR) enterography recommended before CE
Lichtenstein GR et al. Am J Gastroenterol. 2009:104(2):465-483.

• Valuable tool in the diagnosis of small bowel diseases, especially bleeding lesions and CD
• High yield in finding small bowel lesions in CD
• Permits confirmation of diagnosis of small bowel CD when the diagnosis was not possible by other conventional means
• Detected more proximal and middle small bowel cases of CD than did CT enterography and SBFT
• Limitations: false-positive/-negative results (image angle accuracy), no tissue sampling, inter-observer variability, risk of retention
Rey JF et al. Endoscopy. 2006;38(10):1047-1053.

• Small bowel CE (SBCE) should be reserved for cases in which ileocolonoscopy plus small bowel radiography is not diagnostic, but the suspicion of Crohn’s disease remains high
• SBCE may be better than small bowel follow-through or enteroclysis at identifying small bowel mucosal lesions consistent with Crohn’s disease
• SBCE may be superior to MR enterography for detection of mucosal lesions consistent with Crohn’s disease
• SBCE may be superior to CTE or CT enteroclysis for detection of mucosal lesions consistent with Crohn’s disease
Bourreille et al. Endoscopy 2009;41:618-637.

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• CE may play an important role in the evaluation of some patients with known or suspected CD 1
• More sensitive for assessing small bowel mucosal lesions in adult and pediatric patients than any other imaging technique 1,2
• Shown to be superior to ileoscopy, push enteroscopy, small bowel radiography (SBFT and enteroclysis), CT enterography, and small-bowel MR imaging
• Negative CE findings in pediatric patients could likely exclude CD, whereas other imaging techniques tend to yield higher numbers of false-positive results
1. Kornbluth A et al. Endoscopy. 2005;37(10):1051-1054.
2. Mergener K et al. Endoscopy. 2007;39(10):895-909.

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• Can be a useful adjunctive test (e.g., with colonoscopy with ileoscopy) to discriminate between
CD and UC in patients with IC 1,2
• Can identify small bowel lesions better than other imaging methods; more sensitive than serological markers
• CE can lead to changes in therapy based on the extent and/or severity of the inflammation found in the small bowel 1
1. Mergener K et al. Endoscopy. 2007;39(10):895-909.
2. Kornbluth A et al. Endoscopy. 2005;37(10):1051-1054.

• CE can identify small bowel mucosal lesions not seen with other imaging modalities and may, therefore, play an important role in the evaluation of patients with known or suspected CD
• For known CD, CE may be useful in the evaluation of unexplained symptoms
• May also prove to be of value in the evaluation of IC
• May have a unique role in assessing mucosal healing after medical therapy and for assessing early postoperative recurrence and for guiding therapy
• May serve as a subclinical marker in asymptomatic family members and may contribute to the understanding of the natural history of IBD
Kornbluth A et al. Endoscopy. 2005;37(10):1051-1054.

• CE is a less invasive technique for evaluating the small intestine for Crohn’s involvement
• In prospective, blinded evaluations, CE was demonstrated to be superior in its ability to detect small bowel pathology missed on small bowel radiologic studies and CT radiologic examinations
• Small bowel CE (SBCE) should be reserved for cases in which ileocolonoscopy plus small bowel radiography is not diagnostic, but the suspicion of Crohn’s disease remains high
• CE can lead to changes in therapy based on the extent and/or severity of the inflammation found in the small bowel