FDAnews
www.fdanews.com/articles/84418-digestible-video-camera-as-alternative-to-endoscopy

DIGESTIBLE VIDEO CAMERA AS ALTERNATIVE TO ENDOSCOPY

February 8, 2006

Two independent studies concluded that Given Imaging's PillCam ESO is an accurate, noninvasive alternative to upper endoscopy, the current "gold standard" for evaluating patients and the most commonly performed procedure in detecting esophageal varices in cirrhotic patients, according to the January issue of the journal Endoscopy.

Given Imaging is developing a complete line of PillCam video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the Given Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient.

"Both American and European societies recommend that cirrhotic patients be screened to detect esophageal varices and portal hypertension," Gavriel Meron, president and CEO of Given Imaging, said in a press statement. "We believe this data will prove interesting to insurers and lead them to reimburse for PillCam ESO as a screening tool for these indications."

Chronic liver disease affects 360 out of every 100,000 people in the U.S., results in 300,000 hospitalizations annually, and costs over $2 billion a year, according to the National Institutes of Health. The two most common diseases are cirrhosis and fibrosis of the liver. In cirrhosis of the liver, scar tissue replaces normal, healthy tissue, blocking the flow of blood through the organ and preventing it from working as it should. Portal hypertension and esophageal varices are two of the main complications of the disease.