Given Imaging Ltd. (NASDAQ: GIVN), the global leader in capsule endoscopy, today announced the launch of its second-generation PillCam® COLON capsule at the Gastro 2009 Conference taking place in London. Like Given Imaging's other capsule endoscopes, PillCam® SB and PillCam® ESO, PillCam COLON could be a more patient-friendly tool for imaging the gastrointestinal tract.
This advanced PillCam system contains proprietary, innovative technologies, including intelligent functionality and superior imaging, designed to provide physicians with clear and precise views of the colon and polyps of interest. Following receipt of the CE mark in September 2009, Given Imaging will start marketing PillCam® COLON 2 in select European countries with availability throughout Europe expected by mid-2010.
The Company also announced that independent investigators presented results of a 98-patient feasibility study. The investigators concluded that PillCam COLON 2 is a safe and effective method to visualize the colon and detect colonic polyps. An article discussing the study has been accepted for the December 2009 edition of the journal Endoscopy.
High Sensitivity and Specificity
Results of the study comparing PillCam COLON 2 to colonoscopy, showed a sensitivity of 89 percent and a specificity of 76 percent in detecting polyps greater than or equal to 6 mm and a sensitivity of 88 percent and a specificity of 89 percent in detecting polyps greater than or equal to 10 mm. Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam COLON 2 in 98 patients who had risks or warning symptoms of colon pathology. Like Given Imaging's other PillCam capsules, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure, offering physicians and patients a convenient way to visualize the colon.
"The data for PillCam COLON 2 are promising and suggest it may be a safe, minimally invasive option for visualizing the colon in patients who are unwilling to undergo colonoscopy, have undergone an incomplete examination, or those for whom colonoscopy is contraindicated. We are encouraged by the data, which suggest that PillCam COLON 2 could be a reliable alternative to conventional colonoscopy for these types of patients," said Prof. Rami Eliakim, Chairman of Medicine and Director of the Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel.
New Features of PillCam COLON 2
Breakthrough technology offered in PillCam COLON 2 and the PillCam Platform enables a more patient-friendly option for visualizing the colon. New features include:
Intelligent Functionality
Bi-directional communication between PillCam Colon 2 and the DataRecorder enables tracking of the capsule's motion in the GI tract so that the image capture rate can be adjusted to maximize colon tissue coverage.