Capsule Endoscopy Device Cleared For Crohn’s Diagnosis In Japan

In short

We recently covered the story of Israeli company Given Imaging’s Pillcam and the issuance of guidelines relating to the use of such capsule endoscopes. That item can be found here. Now Given Imaging, the self-styled pioneer of capsule endoscopy, has 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 visualisation and diagnosis of Crohn’s disease.

Background 

Given Imaging offers health care providers a range of innovative options for visualising, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® video capsules for the small bowel, oesophagus and colon, industry-leading ManoScan™ high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products.

Japan’s 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. Now following MHLW’s expansion of the potential application of the technology into visualisation and diagnosis of Crohn’s disease, the Company expects to receive reimbursement for this indication at a later date.

Adjunctive to its capsule endoscopes, 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.

Clinician comments 

“PillCam SB has changed the way gastroenterologists in Japan diagnose and treat small bowel disease,” said Dr. Akira Terano, M.D., Ph.D., 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.”

Company comments 

“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.”

Source: Given Imaging, Marketwire