The new indication covers the detection of colon polyps in patients with bleeding in the lower gastrointestinal tract who’s health is at risk from colonoscopy or mild sedation, but could tolerate them if the Pillcam device detects an abnormality.
The vitamin-sized Pillcam is designed to provide images as it passes through the gastrointestinal tract after being swallowed. Covidien acquired its maker, Given Imaging, for $860 million in February 2014; Medtronic paid $50 billion for Covidien in January 2015.
“We are committed to the early detection and treatment of chronic GI diseases and cancers. We are pleased with the FDA’s decision to clear this expanded indication for PillCam Colon capsule which will provide access to more patients who can benefit from this technology,” early technologies president Vafa Jamali said in prepared remarks.
“The ability to offer PillCam Colon capsule to an expanded patient group represents a significant breakthrough in GI healthcare,” added Dr. Douglas Rex of the Indiana University School of Medicine. “The new indication allows gastroenterologists to provide their at-risk patients with a non-invasive and radiation free alternative to traditional colonoscopy.”