Given Imaging plans to launch its PillCam COLON 2 endoscopy capsule in Europe this year and expects it to overcome many of the limitations of the first-generation PillCam COLON .
The Israeli firm is currently finishing some R&D trials of the device in Israel and aims to launch the "revolutionary technology" at the Gastro 2009 conference in London in November, according to Given CEO Homi Shamir. The Gastro meeting is sponsored by the United European Gastroenterology Federation.
Once PillCam COLON 2 is launched in Europe, the company expects to announce its plans for a U.S. clinical trial that will eventually support an FDA submission, Shamir said. The firm is currently in discussions with the agency about the design of the pivotal trial, but cannot discuss details at this time.
The company believes availability of a colonoscopy capsule as an alternative or complement to standard optical colonoscopy will increase patient compliance with colorectal cancer screening guidelines. Previous studies have shown that patients prefer the PillCam procedure to standard endoscopy screening procedures which many patients consider uncomfortable and inconvenient, according to Given.
The first-generation PillCam COLON received a CE mark in 2006 and is available in Europe, Israel, Asia, Latin America, Canada and Australia.
FDA rejected the firm's 510(k) for the device in 2008, deeming it to be not substantially equivalent to an approved predicate device. The company says it is not planning to file another 510(k) or PMA for the first-generation PillCam COLON.
FDA has cleared PillCam SB 2 , for the small bowel, and PillCam ESO 2 , for the esophagus.
PillCam Does Not Meet Standard In Belgian Study
The limitations of the current version of the PillCam COLON were demonstrated in the results of a study published in the July 16 issue of the New England Journal of Medicine by researchers at the Erasme University Hospital, Belgium.
The Belgian study, which was supported by Given, randomized patients with known or suspected colonic disease to colon imaging with the PillCam COLON or optical colonoscopy ("the gold standard"). Both imaging modalities are intended to detect polyps, advanced adenoma or cancer.
The sensitivity of the PillCam COLON test is calculated as the percentage of the patients who had a positive finding with the capsule endoscopy among those who had a positive finding with standard optical colonoscopy.
The specificity of the PillCam COLON test is calculated as the percentage of patients who had negative findings with the capsule endoscopy among those who also had a negative finding with standard optical colonoscopy.
The sensitivity and specificity of capsule endoscopy for detecting polyps 6 mm in diameter or greater was 64% and 84%, respectively. For adenoma, the sensitivity and specificity were 73% and 79%, respectively. The PillCam COLON detected 14 of the 19 cancers that were found by optical colonoscopy.
PillCam COLON's sensitivity was higher in patients in whom pre-test cleaning of the colon with a polyethylene glycol and water solution was deemed good or excellent than in patients whose colon cleanliness was fair or poor.
Mild-to-moderate adverse events were found in 7.9% of patients, usually related to colon preparation.
Although the study showed that colonoscopy with PillCam COLON was not as sensitive or specific as the gold standard, "the data show that this first-generation PillCam COLON is safe and can visualize the colon," co-primary investigator Jacques Deviere, M.D., says in a Given release.
"We believe that with the scheduled upgrades in capsule technology in [COLON 2], more efficient colon preparation and higher rates of adequate colon cleansing among patients, PillCam COLON could be a promising new tool to complement colonoscopy for detection of polyps and diagnosing colorectal cancer."
This article first appeared in 'The Gray Sheet.' on July 16 2009. Visit our Web site to sign up for a free trial.
- Reed Miller (re.miller@elsevier.com)
