Indications and Risks

INDICATIONS

The PillCam Platform with PillCam SB capsules is intended for visualization of the small bowel mucosa and:

  • May be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy
  • May be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy
  • May be used in the visualization of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy

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

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

Contraindications

  • Patients with known or suspected GI obstructions, strictures or fistulas based on the clinical picture or pre-procedure testing and profile
  • Patients with cardiac pacemakers or other implanted electromedical devices
  • Patients with swallowing disorders

Procedure Risks

  • The risks of PillCam capsule endoscopy include capsule retention, aspiration or skin irritation. 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 SB 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 consult your physician for further information.

About Medtronic

As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges — such as rising costs, aging populations, and the burden of chronic disease — faced by families and healthcare systems today. But, we can't do it alone. That's why we're committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes.

Our GI business is dedicated to patient-friendly innovations, providing actionable diagnostic information and reliable treatments to enable early detection and treatment of chronic GI diseases and conditions.

Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 85,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. Join us in our commitment to take healthcare Further, Together. Learn more at Medtronic.com.

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