Expanded Use of PillCam Gets Green Light in Japan

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YOQNEAM, ISRAEL—Given Imaging, a developer of specialty GI products, including capsule endoscopy, this week announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has cleared the PillCam Patency Capsule for use with PillCam SB and expanded the indications for use of the PillCam SB video capsule for patients with known or suspected small bowel disease, including the visualization and diagnosis of Crohn's disease.

The PillCam Patency Capsule is a dissolvable capsule that enables physicians to determine whether there are obstructions or strictures in the small bowel that may prevent passage of the PillCam SB video capsule.

"PillCam SB has changed the way gastroenterologists in Japan diagnose and treat small bowel disease," said Dr. Akira Terano, MD, PhD, emeritus president, Dokkyo Medical University, Tochigi, Japan and Chairman, Japan Association for Capsule Endoscopy. "The expanded clearance means that physicians have a new tool to help them safely diagnose and monitor a broader group of patients with GI diseases, including those individuals who are suffering from Crohn's disease in Japan today."

MHLW approved the PillCam SB capsule in April 2007 for visualizing obscure gastrointestinal bleeding (OGIB). The entire 105-million adult population of Japan has been eligible for reimbursement for the PillCam SB procedure to visualize OGIB since October 2007. The company expects to receive reimbursement for the expanded indication at a later date.

"We are very pleased that physicians in Japan will be able to utilize PillCam SB to help monitor and manage their patients with GI diseases like Crohn's disease," said Homi Shamir, president and CEO, Given Imaging. "Given Imaging is the only company to offer a patency capsule to customers in Japan, providing doctors with a much needed tool to ensure the safe and effective use of PillCam SB in patients with suspected strictures."

Crohn's disease is a chronic condition that causes inflammation in the lining of the small intestine wall and can affect any part of the digestive tract. Symptoms can include diarrhea, abdominal pain, weight loss and rectal bleeding. In approximately 75 percent of Crohn's disease patients, the small bowel (duodenum, jejunum and/or ileum) is involved and in 30 percent of Crohn's disease patients, the small bowl is the only segment involved.

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