Given Imaging Ltd, a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that Japan''s Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for the PillCam SB 3 system.
The innovative technology in this third-generation system will provide physicians throughout Japan, the world''s second largest healthcare market, with the most advanced PillCam capsule endoscopy technology to detect and monitor small bowel diseases, such as Crohn''s disease.
"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."
Each component of the PillCam SB 3 system, including the capsule, recorder, sensor belt, and software, has been enhanced to work together to improve image quality, tissue coverage and efficiency. New adaptive frame rate technology also 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. 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 to begin recognizing sales of PillCam SB 3 in Japan in 2014.
"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."
Given Imaging will be participating in the upcoming Japan Digestive Disease Week (JDDW) conference taking place between October 9th -12th, 2013 in Tokyo. Company representatives will be available to share information about the newest features and capabilities of the PillCam SB 3 system along with Given Imaging''s entire portfolio of gastrointestinal screening, diagnostic and monitoring products.
About PillCam® SB 3
The PillCam SB 3 capsule is a minimally invasive procedure to visualize and monitor small bowel abnormalities associated with Crohn''s disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its third generation, PillCam SB 3 contains an imaging device and light source and transmits images at a rate between two and six images per second. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB 3 builds on Given Imaging''s unique expertise and collaborative efforts as an industry leader that includes more than 2 million uses of PillCam capsules in patients worldwide and more than 1,900 clinical studies.
The risks of PillCam capsule endoscopy 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.
About Given Imaging Ltd.
Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan® high resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z monitoring, and SmartPill® motility monitoring systems. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging''s headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam, Hong Kong and Brazil.
