Israel-based medical devices developer Given Imaging has received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its third-generation video capsule PillCam SB3 to detect and monitor small bowel illnesses such as Crohn's disease.
The PillCam SB3 capsule is at the core of a minimally invasive procedure to visualise and monitor small bowel abnormalities associated with Crohn's disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB).
Weighing less than 4g, the 11mm by 26mm video capsule features an imaging device and a light source that can transmit anywhere between two and six images in a second.
Each component of the PillCam SB3 system, including the capsule, RAPID for PillCam software, PillCam recorder, and PillCam sensor belt, has been fine-tuned to work in concert. Together, they vastly improve image quality, tissue coverage and interpretation efficiency.
The latest version of the video capsule provides a 30% more efficient image resolution and comes with adaptive frame rate technology that offers detailed small bowel images and an improved video processing engine.
The capsule uses new adaptive frame rate technology to automatically enhance image capture frequency when it is moving more quickly through the digestive tract.
In addition, the proprietary algorithms in the new RAPID for PillCam software enables even smarter video compilation that is 40% more efficient than with PillCam SB2.
Given Imaging president and CEO Homi Shamir said approval of the PillCam SB3 system in Japan underscores company's global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract.
"The approval of the PillCam SB3 system in Japan builds upon our recent regulatory momentum that includes PillCam COLON in Japan and PillCam SB3 in the US," Shamir said. "Japan is a critically important healthcare market and we look forward to working with physicians there to integrate PillCam SB3's benefits into clinical practice."
In August, the company obtained the US Food and Drug Administration (FDA) approval for PillCam SB3 and anticipates initiating the sales of PillCam SB 3 in the fourth quarter of 2013.
Given Imaging is also planning to begin the sales of PillCam SB3 next year in Japan.
According to GlobalData estimates, Capsule endoscopy market in Japan was valued at $10m in 2012 and is expected to grow at a CAGR of 8.8% to reach $18m by 2019.
Image: PillCam SB 3 video capsule. Photo: courtesy of Globenewswire/Given Imaging.