FDA clears PillCam for Crohns indications

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The FDA has updated its clearance of Given Imaging's PillCam SB video capsule to include use in monitoring lesions that may indicate Crohn’s disease.

The PillCam SB capsule has been cleared since 2001 for the visualization of the small bowel mucosa and may be used as a tool in the detection of small bowel abnormalities in adults and children from two years of age. The updated labeling reflects clinical data supporting the use of PillCam capsule endoscopy for the visualization of lesions in a variety of conditions, such as Crohn's disease, iron deficiency anemia and obscure gastrointestinal bleeding, according to Yoqneam, Israel-based Given Imaging.

"Previously physicians could use PillCam SB capsule endoscopy to detect Crohn's disease, and now we also can use this technology to monitor a patient's response to therapy to assure adequate healing. Studies have concluded that the use of PillCam SB in patients with inflammatory bowel disease, such as Crohn's disease, frequently changes the diagnosis, often resulting in a change in patient therapy, thereby underscoring the clinical impact of this tool," said Blair Lewis, MD, clinical professor of medicine at Mount Sinai Medical Center in New York City.

PillCam SB 2, a second-generation system, contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures during the course of the procedure.