Given Imaging out of Yoqneam, Israel is releasing a new version of PillCam Colon, an endoscopic capsule designed for imaging of the large intestine. The PillCam COLON 2 has recently received European approval and was just unveiled at the Gastro 2009 Conference in London, England.
From the press release:
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.
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.
- 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.
- Adaptive Frame Rate adjusts the image capture rate from four frames per second to 35 frames per second, enabling creation of a smooth, continuous video.
- Polyp Size Estimation is a new research tool that allows clinicians to estimate the size of polyps.
- Superior Imaging Compared to COLON 1
- Advanced optics for enhanced image quality and polyp detection.
- 172 degrees field of view from each imager offers a near 360 degrees view of the colon.
It should also be mentioned that last year FDA has rejected Given Imaging's 510(k) application to market the original PillCam COLON in the United States, citing a 'not substantially equivalent' applicability of the device.
Press release: Given Imaging Launches Next-Generation PillCam(R) COLON 2 at GASTRO 2009 Conference...
Product page: PillCam COLON...
Flashbacks: PillCam Colon; FDA Rejects PillCam Colon
[Medgadget via Globes Online]