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.
