PillCam Colon gets de novo FDA Pass for use in Resolving Incomplete Colonoscopy

Capsule Endoscopy company Given Imaging Ltd, has seen the U.S. FDA clear PillCam COLON as a new modality to provide visualization of the colon. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.

Background

We’ve covered the story of Given Imaging’s progress with the Pillcam franchise for a few years now, including the ongoing sale of the company to Covidien, which is expected to complete in a couple of months from now. Given Imaging has meantime been enjoying a foray into gaining regulatory approval for a variety of indications for its devices, including the resolution of incomplete colonoscopy problems with PillCam Colon.

Incomplete colonoscopy is a surprisingly common occurrence, often resulting in additional costs for fee paying patients, along with the inconvenience and risk of other procedures to complete the colorectal examination. PillCam Colon may offer a solution as it is indicated for use in detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.

The PillCam COLON video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source. Measuring only 12 mm X 33 mm, the device is designed to be ingested by the patient and transmits 4 or 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer to enable the physician to review and report the results of the PillCam study.

Last year Given Imaging reported results from an 884-patient, 16-site clinical trial studying the accuracy and safety of PillCam COLON 2, comparing the device with optical colonoscopy in detecting adenomas 6 millimeters or larger.

Trial results demonstrated that the sensitivity for PillCam COLON was 88% and specificity was 82% in detecting adenomas at least 6 millimeters in size.

The FDA based its clearance decision on an analysis of this clinical trial data that used a more restrictive methodology for matching polyps. In this analysis, which was conducted on hyperplastic polyps and adenomas, the positive percent agreement for PillCam COLON and optical colonoscopy was 69% and negative percent agreement was 81% for polyps at least 6 millimeters in size.

Physician comments

“PillCam COLON will improve patient care by offering a new and effective colon imaging option for patients who have experienced an incomplete colonoscopy. Among the limited alternatives available after incomplete colonoscopy, PillCam COLON gives us a minimally invasive, radiation-free option that provides endoscopic images of the same basic type that have made colonoscopy so useful,” said Douglas Rex, M.D., Distinguished Professor of Medicine and Chancellor’s Professor, Indiana University School of Medicine and Director of Endoscopy, Indiana University Hospital.

Company comments

“We have made tremendous strides in increasing the number of people who are getting screened for colon cancer, starting at age 50 for the average risk individual. Colonoscopy is the most comprehensive option, but for up to 10% of individuals, achieving a complete colonoscopy may not be possible. For those individuals, PillCam COLON capsule endoscopy could be an effective option to allow their gastroenterologist to complete a colon examination. And who wouldn’t want that kind of peace of mind for this unique cancer — that we can largely prevent with the aid of diagnostic exams that detect the presence of polyps,” said Eric Hargis, CEO, Colon Cancer Alliance.

“The clearance of PillCam COLON by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader. This important event caps a string of significant regulatory milestones for our company including clearance of PillCam COLON in Japan and PillCam SB 3 in both the U.S as well as Japan. 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,” said Homi Shamir, President and CEO, Given Imaging. “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.”

Source: Given Imaging, Ltd., Globe Newswire

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