FDA Clearance for Next Generation PillCam
Improved PillCam SB Technology Provides a More Detailed and Efficient Small Bowel Examination for Patients With Conditions Such as Crohn's Disease and Obscure GI Bleeding
Given Imaging Ltd., a world leader in GI medical devices and the pioneer of capsule endoscopy, today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the next generation PillCam, SB 3, to detect and monitor small bowel abnormalities associated with Crohn's disease, obscure gastrointestinal (GI) bleeding and iron deficiency anemia.
"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 U.S. and across the globe," said Homi Shamir, President and CEO, Given Imaging. "We believe PillCam SB 3 will both enhance the clinical experience for our large base of existing U.S. customers and expand the market for this product among new physicians who have not been performing PillCam procedures."
The PillCam SB 3 system combines a 30% improvement in image resolution with adaptive frame rate technology to deliver more detailed small bowel images and coverage. In addition, PillCam SB 3's video processing engine has been significantly improved. Proprietary algorithms in the system's new software enable even smarter video compilation that is 40% more efficient than PillCam SB 2.
"Patients with complicated diseases involving the small bowel, such as Crohn's disease, often struggle to comprehend what is happening inside their bodies and how it can be better managed," said Felice H. Schnoll-Sussman, M.D., Director, Jay Monahan Center for Gastrointestinal Health, New York-Presbyterian Weill Cornell Medical Center. "The improved image resolution and overall efficiency of the PillCam SB 3 system in capturing and analyzing images of the small bowel has potential to have a meaningful impact on patient care."
"Our goal as we set out to reimagine and improve the PillCam platform was not just to provide physicians with more information, but to provide them with better and more actionable information. By delivering more detail, more coverage and improving the overall efficiency of our technology platform, we have achieved this with PillCam SB 3," said Homi Shamir. "Given Imaging is committed to helping physicians integrate PillCam SB 3 into clinical practice and improving patient access to this new innovative technology both in the U.S. and across the globe."
The U.S. clearance of PillCam SB 3 represents the second regulatory milestone for Given Imaging in 2013. In July, the Company reported that PillCam COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency. PillCam SB 3 will be available in the U.S. beginning in Q4 2013.