YOQNEAM, ISRAEL -- Given Imaging Ltd. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next-generation PillCam® ESO 2 video capsule for imaging the esophagus. Exclusive U.S. marketing rights for PillCam ESO have been granted to InScope, a division of Ethicon Endo-Surgery, a Johnson & Johnson company.
Homi Shamir, president and CEO of Given Imaging, said, "We wanted to develop an esophageal video capsule that would give physicians a more precise view of a patient's mucosa and suspected pathology, and we believe we accomplished that with the advanced optics and wider view range of PillCam ESO 2. This next-generation esophageal video capsule is designed to help physicians more easily diagnose disorders such as Barrett's esophagus and esophageal varices, a dangerous complication of liver cirrhosis."
PillCam ESO 2 features include:
-- Improved image quality
-- A 21 percent increase in the angle of view over PillCam ESO, providing physicians more than a 100 percent increase in mucosal tissue coverage
-- Added Automatic Light Control (ALC) to provide optimal illumination for each image
-- Increased capture rate of 18 frames per second (fps), capturing 30 percent more images
-- Up to 30 minutes operating time
-- Same dimensions as PillCam ESO.
PillCam ESO 2 will be supported by the PillCam® Platform with RAPID® 5 software and available for shipment to customers before the end of the year.
Source: Given Imaging