Throat PillCam gets FDA go ahead
The company has also submitted a new application to the FDA for a higher frame rate version, which takes 14 frames per second. Given Imaging recently launched the enhanced, higher frame rate PillCam ESO in Europe and will launch in the US pending clearance from the FDA.
Following FDA clearance of the 14 frame per second PillCam, the Company intends to upgrade its installed base with its RAPID 3 image processing software and an enhanced data recorder. This upgrade will make the existing installed base compatible with the new capsule.
"With this clearance, Given Imaging remains on track for launching the PillCam ESO this year as planned," said Gavriel D Meron, CEO and president of Given Imaging.
In a multi-centre pivotal study of 106 patients for the FDA clearance, the PillCam ESO video capsule demonstrated comparable efficacy to conventional endoscopy in visualising esophageal pathology. The investigators found the PillCam ESO video capsule to be a convenient, safe and sensitive method for detecting esophageal lesions and suggested that it could be an effective tool for screening patients with esophageal disorders such as detecting visual signs of Barrett's esophagus, a pre-cancerous condition.
The PillCam ESO will be commercialised through an alliance with InScope, a division of Ethicon Endo-Surgery. Upon receipt of clearance for the higher frame rate PillCam ESO video capsule, Given will be entitled to a milestone payment of $10mn from Ethicon Endo-Surgery.
Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel.
