PillCam™ Patency Capsule Patient Safety is our Priority

When is the Patency of the Gastrointestinal Tract proven?

PillCam™ Patency Capsule – Safety is our Priority

Capsule Body

RFID Tag

• Dissolvable capsule• Provides a simple examination to verify functional patency of the GI tract• Shape and size comparable to the PillCam™ SB capsule• Radiation-free procedure

If the PillCam™ Patency capsule is excreted within 30 hours or if the capsule body is intact when excreted.

Intact Capsule

Body and Plugsare virtually intact.

Intact Body

Body is intactand hard. Plugs

have eroded.

Disintegrating Body

Body is losing its original

dimensions and is becoming soft.

Empty Shell and Tag

Capsule contentshave disintegrated.

INDICATION

When is a Patency Test needed?

According to pooled results on retention rates of small bowel capsule endoscopy from more than 220 studies involving more than 22,000 procedures, pooled retention rates are as follows:

Obscure GI Bleeding

Neoplastic Lesions

Definite or Suspected Crohn’s Disease

Overall (weighted average)

1.2%

2.1%

2.6%

1.4%

RETENTION RATE

Liao et al, Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review, Gastrointestinal Endosc. 2010 Feb;71(2):280-6.

The risk of capsule retention in patients with suspected Crohn´s disease without obstructive symptoms and without a history of small bowel resection or known stenosis is low and comparable to that of obscure GI bleeding.1

Non-standard in patients with suspected Crohn's

disease

Standard in patients with established

Crohn's disease

The latest ESGE guideline recommends PillCam™ Patency Capsule as per the following:

IMPORTANT: Please refer to the package insert for complete instructions, contraindications, warnings and precautions.

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PillCam™ Patency Capsule is the best Exam to prove GI Patency prior to a CE Exam3

Fibrostenosing Stricture in SBSmall Bowel Stricture

Radiographic evidenceindicates strictures

Stricture

Small Bowel Stenosis With CE

• The PillCam™ Patency capsule detects stenotic areas in the small bowel and differentiates inflammatory strictures (functional patency) from fibrotic strictures4

• The PatCap might be superior to CT in predicting intestinal stricture, as it detects stenosis undiagnosed by CT. CD patients should be examined with the intestinal patency by PatCap before VCE5

• 100% of patients with a suspected stricture in MRE could be safely evaluated by CE after a correct expulsion of the Agile Patency Capsule6

3DGVS Positionspapier 2010, Kapselendoskopie in der Diagnostik von Dünndarmerkrankungen.Update des Positionspapiers der Sektion Endoskopie der DGVS, Stand 07/2010.4Caunedo-Alvarez et al, Patency and Agile capsules, World Journal Gastroenterology 2008:14(34);5269-5273.5n=24, Handa et al, The Usefulness of the Self-Dissolving Patency Capsule in the Prediction of the Intestinal Stricture in Patients With Crohn's Disease: a Prospective Study, GIE 2013; 77(5): Supp AB172.6n=34, Diaz-Gonzalez et al, Capsule endoscopy (CE) is superior to magnetic resonance enterography (MRE) for the assessment of small bowel lesions in Crohn's disease (CD) patients: a comparative trial, GIE 2013; 77(5): Supp AB275.

1Annese, European evidence based consensus for endoscopy in inflammatory bowel disease, Journal of Crohn's and Colitis (2013) 7, 982–1018.2Pennazio, Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline, Endoscopy 2015; 47(04): 352-386.

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