The PillCam ESO video capsule measures 11 mm x 26 mm and weighs less than 4 grams. It contains an imaging device and light source at both ends of the video capsule and takes up to 14 images per second, or 2,600 color images, as it passes down the esophagus during the 20-minute procedure.
PillCam ESO was initially cleared by the U.S. Food and Drug Administration in November 2004. It was developed for patients suffering from esophageal disorders, such as esophageal varices, which can result in fatal bleeding, and Barrett’s esophagus, which is an early indication for esophageal cancer.
The Company’s next generation esophageal video capsule, PillCam ESO 2, was cleared for marketing by U.S. Food and Drug Administration in May 2007. It is the same size as the PillCam ESO video capsule but has a wider angle of view, automatic light control now captures images at a rate of 18 frames per second or 30% more images over PillCam ESO. The indications for this video capsule are similar to PillCam ESO however, the Company believes screening for gastroesophageal reflux disease, or GERD, may also be an indication in the future.
How the Procedure Works
A patient fasts for two hours prior to arriving at the physician’s office. Once he or she arrives they are prepped for the procedure. This includes attaching the sensor array to the patient’s chest and the data recorder to a belt around the patient’s waist. Once these tasks have been completed the patient will be given a glass of water to help swallow the vitamin-sized pill while lying on his or her back.
After swallowing the PillCam ESO video capsule, the patient is raised by 30-degree angles every two minutes over a six-minute period until he or she is sitting fully upright. The entire procedure takes approximately 20-minutes and the pill passes naturally with a bowel movement usually within 24 hours.
Images are downloaded by the physician to the Given workstation for review and diagnosis. The proprietary RAPID software installed on the workstation contains an image atlas to help facilitate the analysis.