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FDA Clears Given Imaging's PillCam Colon 2

The Colon 2 PillCam from Given ImagingGiven Imaging Ltd announced on February 3 that the company has received FDA approval of its PillCam Colon 2 as a minimally invasive follow-up for patients receiving an incomplete colonoscopy. It may be used for detection of colon polyps in patients for whom a complete evaluation of the colon was not technically possible. PillCam Colon received clearance as a de novo device with low to moderate risk that has no predicate on the market.

"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."

Approximately 750,000 patients in the United States experience an incomplete colonoscopy every year. Aside from incomplete preparation by the patients, there are several other reasons why the examining physician may not be able to complete the colonoscopy, including a redundant or long colon, history of abdominal surgery, or advanced diverticular disease. The incidence of incomplete colonoscopies is also higher in women due to the anatomical differences of women. An incomplete colonoscopy often incurs additional costs, inconvenience, and the risk of another procedure to complete the colorectal examination.

The PillCam Colon 2 video capsule measures 12 × 33 mm (about 0.5 × 1.4 in.). It  is equipped with a miniature color video camera on each end, an LED light source, a transmitter, and a battery. The device is swallowed 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 this device to a computer that enables the physician to review and report the results of the PillCam study. The Colon device had previously been the subject of a 16-site, 884-patient clinical trial; results of this trial were presented at Digestive Disease Week in May 2013. According to Given, FDA based its clearance decision on an analysis of this clinical trial data.

The Colon 2 device had previously received approval in Japan. In August 2013, Given's PillCam SB 3 received FDA 510(k) clearance to detect and monitor small bowel abnormalities associated with Crohn's disease, obscure gastrointestinal (GI) bleeding and iron deficiency anemia.

As we reported in early December, Given Imaging is being acquired by Covidien Ltd (Dublin). The deal is expected to close in March, following the approval of shareholders and various regulatory agencies. The Israel-based company has branches in the United States as well as in Germany, France, Japan, Australia, Vietnam, Hong Kong and Brazil.

Learn about cutting-edge medtech technologies and trends at MD&M West, which is held February 10-13 in Anaheim, CA.
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