PillCam™ capsules

Indications for Use

The PillCam™ Platform with a PillCam™ SB capsule is intended for visualization of the small bowel mucosa.

• PillCam™ Platform with PillCam™ SB capsule may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
• PillCam™ Platform with PillCam™ SB capsule may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
• PillCam™ Platform with PillCam™ SB capsule may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

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.

Contraindications

The PillCam™ SB capsules are 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 SB PillCam™ Capsule may be deployed by using transendoscopic delivery in patients who are either unable to ingest the PillCam™ capsule or are known to have slow gastric emptying time. Placement into the duodenum is recommended to prevent the patient from vomiting the capsule.

Procedure Risk Information

The risks of PillCam™ SB 3 capsule 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 3 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.

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.

Indications

• The PillCam Capsule Endoscopy System with the PillCam COLON capsule is intended for the visualization of the colon for diagnosis of colonic disorders.
• The PILLCAM™ COLON capsule is intended for use in adults and children from 8 years of age.
  

Contraindications

The PILLCAM™ COLON 2 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 PillCam™ COLON 2 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™ COLON 2 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™ COLON 2 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 product user manual for detailed information.

Indications

The PillCam™ patency system is an accessory to the PillCam™ video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam™ video capsule in adults and children from two years of age with known or suspected strictures.

Contraindications

• The PillCam™ patency capsule is contraindicated for use in patients with swallowing disorders.
• The PillCam™ patency scanner is contraindicated for use in patients with cardiac pacemakers or other implanted electro medical devices.

The capsule is made of Lactose anhydrous, Barium sulphate, Magnesium stearate, Citric acid, Sodium bicarbonate, Avicel PH 200, Compritol 888, PVP K-90. The PillCam patency capsule should not be administered to patients who are hypersensitive to any component.

Procedure Risk Information

• The risks of the PillCam™ patency capsule 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™ patency 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
• Passage of an intact patency capsule does not preclude the presence of an intestinal stricture or other pathology
• Please refer to the product user manual for detailed information