Given Imaging announces first centre of excellence for colon capsule endoscopy

14 May 2012

Given Imaging, a world leader in specialty GI products and pioneer of capsule endoscopy, has announced the designation of the Policlinico Agostino Gemelli in Rome, Italy, as the first colon capsule endoscopy (CCE) Center of Excellence (CoE).

Policlinico A. Gemelli is part of the medical school of the Universita Cattolica del Sacro Cuore, the largest private university in Italy. The announcement took place during the EndoLiveRoma 2012, an international endoscopy symposium including live demonstrations and state-of-the-art lectures.

"We are proud that the Policlinico A. Gemelli has been designated as the first colon capsule endoscopy Center of Excellence," said Professor Guido Costamagna, head of the Digestive Endoscopy Unit, Universita Cattolica del Sacro Cuore, Policlinico A. Gemelli, Rome.

"Over the last four years, we have developed extensive experience in CCE through our participation in several multicenter clinical trials, as well as through academic endeavours such as developing the recently published European Society for Gastrointestinal Endoscopy (ESGE) guidelines on colon capsule endoscopy. We believe that this makes us optimally positioned to educate other clinicians about this valuable diagnostic tool and serve as a reference destination for patients."

"Given Imaging is delighted to designate Policlinico A. Gemelli, an elite healthcare organization recognized for its high quality patient care, expert medical professionals and support of scientific innovation, as our first Center of Excellence for colon capsule endoscopy," said Homi Shamir, president and CEO, Given Imaging.

Gemelli continues to be a respected source for physician and nurse education regarding colon capsule endoscopy for its colleagues around the world. Such efforts should help to increase awareness about the role and benefits of colon capsule endoscopy in the visualization of colonic mucosa and expand the use of PillCam(R) COLON 2 in Europe," he added.

Complementary to other colon examinations, PillCam COLON 2 capsule endoscopy is the only non-invasive exam that provides direct visualization for patients where the risks of other modalities could outweigh the benefits. These patients include those who are at a higher risk for complications due to cardiopulmonary disease or use of blood thinning medications. In addition, this new technology could provide a solution for patients that refuse colonoscopy or those with a previous incomplete colonoscopy.

PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. Patient-friendly in nature, PillCam endoscopy requires no sedation or insufflation and typically is used on an outpatient basis. With PillCam video capsules for the esophagus, small bowel, and colon, PillCam capsule endoscopy has been clinically validated, as evidenced by more than 1,600 peer-reviewed publications. To date, more than 1.5 million patients worldwide have benefited from PillCam endoscopy.

About PillCam COLON 2

The PillCam COLON 2 video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11.6 mm X 31.5 mm. PillCam COLON 2 is designed to be ingested by the patient and transmit up to 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 RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.

All medical procedures carry some risk. The risks of PillCam capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON 2 capsule endoscopy presents additional risks, including risks associated with the drug products used to prepare the patient for the procedure, which are currently used for colonoscopy, and to move the capsule through the patient's digestive tract faster. It may also present other risks that are unknown. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

PillCam COLON 2 is not cleared for use in the United States and certain other jurisdictions.