Capsule Endoscopy Useful for Crohn's Disease Diagnosis

ORLANDO, Fla., May 21 -- Given Imaging announced today that data from six studies support the use of capsule endoscopy for the diagnosis and evaluation of Crohn's disease. The findings were presented at Digestive Disease Week 2003, being held this week in Orlando.

Crohn's disease is an inflammatory condition of the gastrointestinal tract that occurs predominately in the small intestine. It is a chronic condition that historically has been difficult to diagnose, as symptoms vary among patients. Until capsule endoscopy, physicians have used a variety of procedures for diagnosis, including endoscopy and barium x-ray.

Given, based in Israel, makes the Given Diagnostic System, which uses a disposable miniature video camera contained in a capsule that is ingested by the patient. It features the M2A capsule endoscope, a noninvasive device for direct visualization of the entire small intestine. The M2A capsule passes through the digestive tract, transmitting high-quality color images without interfering with the patient's activities. The system received clearance from the FDA in August 2001, and Given received permission to use the CE mark in May 2001.

The M2A has been used to diagnose a variety of diseases of the small intestine, including Crohn's Disease, celiac disease and other malabsorption disorders, benign and malignant tumors of the small intestine, vascular disorders, medication-related small-bowel injuries and pediatric small-bowel disorders.

"Capsule endoscopy will play an important role in the diagnosis of Crohn's disease," said Asher Kornbluth, MD, of Mount Sinai Medical Center. "It may also prove a very valuable tool in patients after surgery for Crohn's disease as a predictive tool as to which patients require preventative medical therapy. Capsule endoscopy will also have a role in ruling out Crohn's disease or other inflammatory lesions in a subset of irritable bowel syndrome patients, one of the most common gastroinstestinal conditions."

Studies were also conducted at Northwestern University; Cedars-Sinai Hospital; Humboldt-Universitat, Berlin, Germany; Hospital Da Trofa, Porto, Portugal; and Emory University.

For more information, visit: www.givenimaging.com