FDA Gives Marketing Clearance for PillCamMay 18, 2007
Given Imaging receives U.S. marketing clearance for PillCam SB 2 and RAPID 5 software. Company to introduce products at Digestive Disease Week 2007.
YOQNEAM, ISRAEL -- (MARKET WIRE) -- May 17, 2007 -- Given Imaging Ltd. (NASDAQ: GIVN), the global leader in capsule endoscopy, today announced that it has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its PillCam SB 2 video capsule and RAPID 5 Software. Both products can be viewed at the Company's booth # 2419 at Digestive Disease Week (DDW) 2007 taking place in Washington, DC from May 19–24.
"We're excited to introduce PillCam SB 2, our next generation small bowel video capsule, together with RAPID 5, an enhanced version of our proprietary software," said Homi Shamir, president and CEO of Given Imaging. "These new products are the forefront of capsule endoscopy technology and demonstrate our strategic leadership and commitment to innovation."
The PillCam SB 2 video capsule offers advanced optics and a wider field of view for imaging the small bowel. It has the same dimensions as the Company's flagship PillCam SB and captures nearly twice the mucosal area per image compared to PillCam SB. PillCam SB 2 also provides Automatic Light Control for optimal illumination of each image.
RAPID 5 supports the Company's next generation of PillCam video capsules including PillCam SB 2, PillCam COLON and PillCam ESO 2, with the last two still pending FDA clearance. The software includes new tools to improve a physician's reading efficiency of PillCam endoscopy videos and increase diagnostic confidence. New RAPID 5 features include:
- QuickView v5 -- Allows fast preview of PillCam video images and identifies images that may be of interest to the reviewer;
- The Lewis Score -- Provides an approximate measure of mucosal damage. Combined with other clinical parameters such as patient history and previous diagnostic tests, the Lewis Score can be used to monitor the progress of patient treatment;
- RAPID Atlas -- Enables the side-by-side comparison of case images with a searchable database of peer-reviewed reference images;
- Colon Track -- This feature indicates where the PillCam COLON video capsule is located
The PillCam SB 2 video capsule and RAPID 5 Software will be introduced at DDW and available for shipment to customers in the second half of 2007.
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19–'24, 2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit its Web site.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. More than 500,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit the company's Web site.
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