February 3, 2014
FDA Clears The Path For Colon Camera Pill
Brett Smith for redOrbit.com - Your Universe Online
Uncomfortable, but a medically important procedure – many colonoscopies cannot be completed due to physiological reasons or a patient’s history of complexities and procedures in their abdomen.
"PillCam COLON will improve patient care by offering a new and effective colon imaging option for patients who have experienced an incomplete colonoscopy,” Dr. Douglas Rex, a professor of medicine at Indiana University School of Medicine, said in a statement from the company. “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.”
Incomplete colonoscopies occur in about 750,000 patients in the United States each year. Patients with incomplete colonoscopies often receive more costs along with the trouble and danger of other procedures to accomplish the colorectal examination. The occurrence of incomplete colonoscopies is greater in women as a consequence of increase in past pelvic operations and the varying anatomy of women that includes significantly acute angles in thin women. Patients with a redundant or particularly lengthy colon, background of abdominal surgery or progressed diverticular disease may also be at a higher risk for enduring 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,” said Eric Hargis, CEO, Colon Cancer Alliance, in the company statement. “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,” Hargis said.
In seeking approval of the camera pill, Given Imaging conducted an 884-patient, 16-site clinical trial investigating the consistency and safety of PillCam COLON compared to optical colonoscopy in finding benign growths 6 millimeters or larger. The outcome of this clinical trial indicated that the sensitivity for PillCam COLON was 88 percent and specificity was 82 percent in finding adenomas at least 6 millimeters in size.
The FDA established its clearance decision on an investigation of this clinical trial data that used a more limited methodology for matching polyps, Given Imaging said. In this analysis, which was conducted on hyperplastic polyps and benign growths, the positive percent match between PillCam COLON and optical colonoscopy was 69 percent and negative percent agreement was 81 percent for polyps not less than 6 millimeters in size.
"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 Homi Shamir, President and CEO, Given Imaging. “We look forward to 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.”
“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,” Shamir added. “To this end, we are making good progress in advancing additional clinical studies that should support the expanded indications."