Given Imaging (Yokneam, Israel) reported the launch of its second-generation PillCam Colon capsule at the Gastro 2009 conference in London. Like its other capsule endoscopes, PillCam SB and PillCam ESO, PillCam Colon could be a more patient-friendly tool for imaging the gastrointestinal tract, the company said.

The PillCam capsules are miniature video cameras that patients ingest.

Following receipt of the CE mark earlier this year (Medical Device Daily, Sept. 16, 2009), Given Imaging said it would start marketing PillCam Colon 2 in select European countries with availability throughout Europe expected by mid-2010.

Israel Raz, chief marketing officer, told listeners Monday during a webcast and conference call that the PillCam Colon 2 takes a "smarter approach" to colon capsule endoscopy compared to the previous generation because it offers "intelligent functionality," "superior imaging," and "convenient workflow."

The company said that the PillCam Colon 2 is equipped with two miniature color video cameras (one on each end), a battery and an LED light source. The PillCam Colon 2 measures 11 mm X 31 mm. Employing intelligent functionality, PillCam Colon 2 transmits up to 35 frames per second for roughly 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study. PillCam Colon 2 received a CE mark this year and will be commercially available in Europe in January, the company said.

Given Imaging said that 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. Other new features of the device include: 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; and Polyp Size Estimation, a new research tool that allows clinicians to estimate the size of polyps.

Raz said the PillCam Colon 2 also includes: advanced optics for enhanced image quality and polyp detection; and 172-degree field of view from each imager offers a near 360-degree view of the colon. In contrast, he said the PillCam Colon 1 only has a 156-degree field of view on each side and has first generation optics.

Additionally, Raz said the second-generation PillCam Colon offers a more convenient workflow because it includes: a regimen manager, which allows the physician to customize regimen procedures in the data recorder; a regimen reminder, designed to activate preset visual and auditory alerts to help patients follow instructions; and new capsule packaging to provide easier access, compact storage, and reduced waste.

"PillCam Colon 2 incorporates the cumulative expertise gained from the first PillCam Colon as well as more than 1 million PillCam capsule ingestions worldwide," said Homi Shamir, president/CEO of Given Imaging. "Despite the small size of this initial study and the relatively low prevalence of polyps, we are very encouraged by this data and look forward to working with leading gastroenterologists in Europe, the United States and other markets to initiate additional clinical trials."

The company also reported that independent investigators presented results of a 98-patient (33 females, 65 males) 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 edition of the journal Endoscopy, the company noted.

Results of the study comparing PillCam Colon 2 to colonoscopy, showed a sensitivity of 89% and a specificity of 76% in detecting polyps greater than or equal to 6 mm and a sensitivity of 88% and a specificity of 89% 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.

"From the outset we defined that colonoscopy was the gold standard for comparison," Prof. Samuel Adler of Bikur Holim Hospital (Jerusalem), a principal investigator in the study, said during the webcast. "In other words, if colonoscopy saw something than it did exist and if colonoscopy did not see something than it did not exist."

Therefore if the capsule detected a polyp but the colonoscopy did not it was considered a false positive. Adler noted that there were 10 patients in the study with false positive findings. Of those, he said two of these false positives "were really not that false" because the colonoscopy did report these polyps but specified that they were slightly smaller than 10 mm. He also noted that five of these patients underwent a second colonoscopy. In one patient the second colonoscopy confirmed the polyp originally found by the PillCam Colon 2, Adler said. In another patient, the second colonoscopy confirmed the presence of the polyp but indicated it was slightly smaller than the capsule finding. For three of these five patients, the capsule finding was not confirmed by the repeat colonoscopy. Adler said that two other patients whose PillCam Colon 2 results were considered a false positive were invited for a second colonoscopy but did not do so.

"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).

Given Imaging said the PillCam Colon 2 will be supported by the PillCam Platform with RAPID C2, based upon RAPID 6 software.

Noting the need for the PillCam Colon, Shamir said during Monday's webcast that colon cancer is the second leading cause of cancer death with more than 1 million new cases and over 500,000 deaths annually. He added that 90% of these deaths are preventable if caught early.

Furthermore, Shamir presented a chart during the webcast that showed a high rate of colonoscopy compliance. According to the chart, 50% of people in the U.S. who should be getting a colonoscopy are not doing so. The non-compliance rate is even higher in Europe, at 75%, and higher still in Japan at 90%.

As with colonoscopy, bowel prep is required prior to a patient using the PillCam Colon 2, Shamir noted.

"Colonoscopy remains the gold standard for detecting colon cancer, but based on this high rate of non-compliance we believe there is a significant opportunity for PillCam Colon 2 in those patients who [are unwilling to undergo colonoscopy]," Shamir said.

Amanda Pedersen; 229-471-4212
amanda.pedersen@ahcmedia.com