Given Imaging launches next-gen colon camera

Given Imaging presented its PillCam COLON 2 product, its second-generation video capsule for examining polyps in the large intestine, at the European Gastroenterology conference in London Monday.

The medical-technology pioneer, which is controlled by Nochi Dankner's IDB group, has begun marketing the tool after receiving approval from the European health authorities in September. The company expects the product to become available throughout Europe by mid-2010.

The conference presentation followed a clinical trial conducted among 98 patients. The efficacy of the PillCam COLON 2 was compared with colonoscopy examinations, the leading means of examining large intestine diseases.

The trial indicated that the camera capsule is able to accurately detect disease in patients in 89% of cases, and accurately rule out disease in 89% of the cases of polyps of 10 millimeters or more.

The results will be published in the December edition of the journal Endoscopy.

Given Imaging's chief financial officer, Yuval Yanai, said that despite the small size of the study, the results were very good. Yanai added that the company is planning a study in 2010 with the aim of obtaining approval from the U.S. Food and Drug Administration to permit marketing of the capsule in the United States.

Yanai also said that the data is well within range of the accuracy required for the FDA to consider the capsule's performance as substantially equivalent to colonoscopy diagnosis.

Failure to meet this criterion would have been grounds for the FDA to have withheld approval of the PillCam COLON first generation product.

The capsule is a good solution for patients who are unwilling or unable to undergo colonoscopy, Yanai said.

Equity analysts note, however, that Given Imaging has not claimed that the video capsule is able to replace colonoscopy as a first-line diagnosis.

Moreover, the performance of the second-generation capsule is reportedly not as good as that of virtual colonoscopy, which is a direct competitor to the capsule as a low invasive diagnostic procedure.