The company is submitting a special 510(k) application to the FDA for a higher frame rate version, which takes 14 frames per second. Given Imaging recently launched this enhanced, higher frame rate PillCam ESO in Europe and will launch in the United States 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 and allow existing customers to obtain the full benefits of the new capsule.
"With this clearance, Given Imaging remains on track for launching the PillCam ESO this year as planned", stated Gavriel D. Meron, CEO and President of Given Imaging. The submission included results of a multi-centre pivotal study of 106 patients in which the PillCam ESO video capsule demonstrated comparable efficacy to conventional endoscopy in visualizing esophageal pathology.
Interim results of the first 80 patients from the pivotal trial were recently presented at the 12th United European Gastrointestinal Week in Prague, Czech Republic. The interim analysis showed 97 percent sensitivity and 100 percent specificity for the PillCam ESO video capsule in detecting pathology in patients with chronic GERD symptoms.
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 chronic GERD symptoms to detect visual signs of Barrett's esophagus, a pre-cancerous condition. Full results of the trial will be presented at the forthcoming 69th Annual Scientific Meeting of the American College of Gastroenterology in Orlando, Florida from October 31st to November 3rd.
The PillCam ESO will be commercialized through the alliance with InScope, a division of Ethicon Endo-Surgery Inc., a Johnson and Johnson company, which was signed between the companies in May 2004. According to the terms of the agreement, upon receipt of clearance for the higher frame rate PillCam ESO video capsule, Given will be entitled to a milestone payment of $10 million from Ethicon Endo-Surgery.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the Given Diagnostic System, featuring the PillCam SB video capsule, a disposable capsule that captures video after it is ingested by the patient. The PillCam SB video capsule is the only naturally-ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 60 other countries and has benefited more than 122.000 patients worldwide.
The company is developing a complete line of PillCam video capsules for detecting disorders throughout the gastrointestinal tract. PillCam ESO video capsule for visual examination of the esophagus is currently under review by the FDA and capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has direct sales and marketing operations in the United States, Germany and France, and local offices in Tokyo, Madrid and Sydney. More information on Given Imaging is available in the VMW June 2003 article Given Imaging to highlight Capsule Endoscopy's growing clinical utility at Digestive Disease Week.