PillCam™ SB Fact Sheet

Overview

• Ingestible capsule equipped with a miniature video camera to visualize the small intestine
• Non-invasive alternative to conventional endoscopic and radiological procedures to help diagnose and evaluate disorders of the small intestine including suspected Crohn’s disease, celiac disease, unexplained bleeding, intestinal cancer, NSAID related ulcer, etc.
• The only device able to visualize all 21 feet of the small intestine, previously visible only by surgery

·        Procedure’s accuracy is comparable to or better than traditional diagnostic and detection methods

 

How it Works

• PillCam SB transmits 2 images per second for eight hours to a recording device worn by the patient.  This results in approximately 50,000 images of the small bowel
• Data is transferred from the recorder belt to the RAPID workstation and used to view, edit, and archive  video images and clips

 

Procedure

·        Patient fasts for 10 hours prior to the procedure

·        PillCam SB Capsule Endoscopy begins when the patient ingests the smooth plastic capsule (the size of a large vitamin) with a glass of water

·        Images and data are acquired as the PillCam SB passes through the digestive system

·        This information is then transmitted via an array of sensors to the DataRecorder affixed to a belt worn around the patient's waist 

·        Total procedure takes approximately 8 hours

·        Natural digestive contractions help propel the disposable PillCam SB through the gastrointestinal (GI) tract, and it is passed naturally and painlessly from the body, usually within 24 hours

 

Benefits over Traditional Methods

·      Offers a simple, safe and non-invasive alternative

·      Does not require sedation

·      Little discomfort

·      Does not require patient to swallow barium or other substances for radiological testing

·      Patient satisfaction

o       Ease of ingestion

o       High comfort during procedure

o       Convenience

·      Immediate recovery

·      Allows patient to continue with normal daily activity

 

Acceptance

• FDA Clearance of PillCam SB – August, 2001; “Adjunctive’ label removed July 2003
• Received CE Mark – May 2001
• ASGE Technology Statements on Capsule Endoscopy
• Over 2300 Systems installed and over 170,000 capsules ingested worldwide
• In the United States, 206 million people now have reimbursable access to capsule endoscopy, with 167 million individuals with coverage for expanded indications
• AMA assigned CPT 91110 for reimbursement of PillCam Endoscopy, effective January 1, 2004