Given Imaging Gets FDA Clearance for PillCam Device

Given Imaging Ltd., a developer of gastrointestinal (GI) medical devices and pill-like capsule endoscopy, received U.S. Food and Drug Administration (FDA) clearance for its PillCam Colon. 

The device can be used to provide visualization of the colon for 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 device received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.

Given Imaging conducted an 884-patient, 16-site clinical trial studying the accuracy and safety of PillCam Colon 2 compared to optical colonoscopy in detecting adenomas 6 millimeters or larger. Results from trial demonstrated that the sensitivity for PillCam Colon was 88 percent and specificity was 82 percent 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 the device and optical colonoscopy was 69 percent and negative percent agreement was 81 percent for polyps at least 6 millimeters in size.

“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 at the Indiana University School of Medicine and director of endoscopy at Indiana University Hospital in Bloomington.

Incomplete colonoscopies occur in approximately 750,000 patients in the United States per year, according to figures cited by the company. Patients with incomplete colonoscopies often incur additional costs along with the inconvenience and risk of other procedures to complete the colorectal examination. The incidence of incomplete colonoscopies is higher in women due to the increase in past pelvic surgeries and the differing anatomy of women that includes particularly acute rectosigmoid angles in thin women. Patients with a redundant or long colon, history of abdominal surgery or advanced diverticular disease are also at a higher risk for experiencing an incomplete colonoscopy.

“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 percent 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 of 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.”

The PillCam Colon video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 12 by 33 millimeters. It is designed to be ingested by the patient and transmits four 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 that uses software to compile the video data and enable the physician to review the results.

Based in Yoqneam, Israel, the company entered an agreement late last year to be purchased be Covidien plc for $860 million. The deal is expected to close in March.