PillCam capsule endoscopy device gains reimbursement approval in Japan

Given Imaging’s miniaturized endoscopic camera device to allow for minimally invasive detection and monitoring of small bowel disease, such as Crohn’s disease, has been approved for reimbursement by Japan’s Central Social Insurance Medical Council, according to a company news release.

Japan’s Pharmaceuticals and Medical Devices Agency cleared the PillCam Colon capsule endoscopy device in July. The Japanese Ministry of Health, Labor and Welfare will determine the indications for use of the device along with the amount for the professional fee in December. The reimbursement rate of about $840 is set to go into effect Jan. 1.

The device is not available in the United States, but the next-generation PillCam SB 3 device was granted 510(k) clearance by the FDA to detect and monitor small bowel abnormalities associated with Crohn’s disease, obscure gastrointestinal bleeding and iron deficiency anemia in August. It is set to become available in the United States during the current quarter.

“With more than 2 million procedures conducted since the first generation of the product was introduced, PillCam SB has had a significant impact on patient care in the US and across the globe,” Homi Shamir, president and CEO of Given Imaging, said in the release. “We believe PillCam SB 3 will both enhance the clinical experience for our large base of existing US customers and expand the market for this product among new physicians who have not been performing PillCam procedures.”

The SB 3 system is designed to offer a 30% improvement in image resolution over the earlier version along with adaptive frame rate technology in order to provide more detailed small bowel images and coverage. The SB 3 video processing also is 40% more efficient than that of SB 2, the release said.