Given Imaging has obtained US Food and Drug Administration (FDA) clearance under the direct de novo classification for its PillCam COLON, designed to assist physicians and patients who are unable to undergo colonoscopy or in cases of an incomplete colonoscopy.
The company believes that PillCam COLON meets a unmet need for a non-invasive and radiation-free solution for visualisation of the colon in patients who experience an incomplete colonoscopy.
There are 750,000 patients in the US alone who experience an incomplete colonoscopy each year, Given Imaging said.
As previously announced at Digestive Disease Week in May 2013, the company evaluated the accuracy and safety of PillCam COLON 2 compared with optical colonoscopy in detecting adenomas 6mm or larger in 884-patient, 16-site clinical trial.
The results from this clinical trial showed 88% sensitivity and 82% specificity in detecting adenomas at least 6mm in size.
FDA's approval is based on an analysis conducted on hyperplastic polyps and adenomas using more restrictive methodology for matching polyps.
The positive percent agreement for PillCam COLON and optical colonoscopy was 69% and negative percent agreement was 81% for polyps at least 6mm in size.
Given Imaging president and CEO Homi Shamir said: "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."
The company anticipates working closely with the US gastroenterology community to bring this clinically proven, diagnostic tool to patients who need to have a thorough colorectal exam following an incomplete colonoscopy.
To date, PillCam COLON clinical data have been validated in 34 publications. PillCam COLON is commercially available in more than 80 markets, including Japan, Europe, Latin America, Canada, Australia and parts of Asia and Africa.
PillCam COLON has a global market of three million procedures a year, the company said.
According to GlobalData estimates, the endoscopy visualisation systems market in the US was valued at $463m in 2012 and is expected to grow at a CAGR of 4.2% to reach $616m by 2019.
Image: PillCam COLON video capsule. Photo: courtesy of Given Imaging Ltd.