Japanese Approval for Given Imaging’s PillCam® SB3

Small bowel endoscopic pill camera

We’ve followed the fascinating story of Given Imaging’s PillCam® for a while now. If you remember, this is the capsule endoscope, designed to image the bowel without the requirement for traditional endoscopy. Given Imaging has now announced Japanese approval for its PillCam SB3 iteration, this being the most advanced version of the system, optimised for detection of small bowel diseases including Crohn’s disaease.

Background

The PillCam SB 3 system, comprising the capsule, recorder, sensor belt, and software, has been enhanced to work together to improve image quality, tissue coverage and efficiency. One clever new feature, the so-called adaptive frame rate technology, allows the capsule to automatically increase the rate at which images are taken when it senses it is moving more quickly through the digestive tract. Given Imaging says improvements in the new system’s RAPID® for PillCam software enable even smarter video compilation, which is 40% more efficient than with PillCam SB 21.

The company expects sales of PillCam SB3 to commence in Japan in 2014.

Physician comments

“With its higher resolution and improvement in capturing images of the small bowel mucosa, the new PillCam SB 3 capsule endoscopy system provides us with enhanced performance and efficiency,” said Tetsuya Nakamura, M.D., Ph.D., Professor and Director, Department of Medical informatics, Dokkyo Medical University. “With these improvements, along with recently receiving an expanded indication, PillCam SB will continue to play an important role in the diagnosis and treatment of small bowel diseases in Japan.”

Company comments

“Approval of the PillCam SB 3 system in Japan underscores our global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract,” said Homi Shamir, President and CEO, Given Imaging. “The approval of the PillCam SB 3 system in Japan builds upon our recent regulatory momentum that includes PillCam COLON in Japan and PillCam SB 3 in the U.S. Japan is a critically important healthcare market and we look forward to working with physicians there to integrate PillCam SB 3’s benefits into clinical practice.”

Source: Given Imaging Ltd., Globe Newswire