Days before becoming part of Covidien, Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) achieved a significant milestone: US Food and Drug Administration (FDA) approval for PillCam COLON. The FDA has allowed Given Imaging, manufacturer of camera pills for digestive tract diagnosis, to market the pill for use in patients after an incomplete optical colonoscopy. According to company data, this means roughly 750,000 patients each year, such that Given Imaging’s potential market is in the hundreds of millions of dollars.

The pill was approved for visualization and detection of colon polyps in patients after an incomplete optical colonoscopy, with adequate preparation. This includes, for the most part, small-framed women, and patients with particularly long intestinal tracts, or a history of stomach surgeries. The pill received clearance under the direct de novo classification for devices with low to moderate risk that have no precedent on the market.

"The clearance of PillCam COLON by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader,” said Given Imaging President and CEO Homi Shamir. “We look forward to working closely with the U.S. gastroenterology community to bring this clinically-proven, diagnostic tool to patients who need to have a thorough colorectal exam following an incomplete colonoscopy. While we believe that PillCam COLON will ultimately play an important role in both the global colorectal cancer diagnostic and screening market, this initial indication is an important first step. To this end, we are making good progress in advancing additional clinical studies that should support the expanded indications."

In the past two months, Given Imaging received approval to market the pill in Japan, as well as approval to market their next-generation pill, SB3, for small intestine diagnosis, in Japan and the US.

Given Imaging’s shareholders, the foremost among them being IDB Holding Corp. Ltd. (TASE:IDBH), recently approved the sale of the company, for close to $1 billion, to Covidien. The deal will be completed by the end of February.

Published by Globes [online], Israel business news - www.globes-online.com - on February 3, 2014

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