PillCam SB
The PillCam SB video capsule measures 11 mm x 26 mm and weighs less than 4 grams. It contains an imaging device and light-source on one-side and transmits images at a rate of 2 images per second generating more than 50,000 pictures over an 8-hour period.
PillCam SB was initially cleared by the U.S. Food and Drug Administration in 2001 and today is used by physicians to detect and diagnose disorders of the small intestine. This includes Crohn’s disease, small bowel tumors, malabsorption disorders (such as celiac disease), GI injuries induced by extended NSAID use and suspected GI bleeding of the small bowel.
The Company’s next generation small bowel video capsule, PillCam SB2, was cleared for marketing by U.S. Food and Drug Administration in May 2007. It is the same size as the PillCam SB video capsule and offers advanced optics and a wider field of view to image the small intestine. PillCam SB2 also captures nearly twice the mucosal area per image.
How the Procedure Works
A patient fasts starting at midnight the day before the procedure. The following morning they arrive at the physician’s office where they are prepped for the procedure. This includes attaching the sensor array to the patient’s abdomen 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. The patient can resume daily activities once he or she has successfully swallowed the PillCam video capsule. After 8-hours the patient returns to the physician’s office to return the device 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.
PillCam ESO
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 ESO2, 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.
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.
Agile Patency System
The Agile Patency System is an accessory to the PillCam video capsule. It is used to verify adequate patency of the GI tract. The non-imaging Agile patency capsule was designed for patients who are contraindicated for PillCam SB due to the suspicion of strictures. A physician can safely recommend PillCam SB if functional patency can be demonstrated with the Agile patency capsule. The system was cleared for marketing in the U.S. in May 2006.
Hardware
Given Workstation
The PC-based workstation is pre-installed with RAPID software. It offers physicians a user-friendly, HIPAA-compliant interface for viewing and interpreting images captured by the PillCam video capsules.
DataRecorder
The data recorder is a small portable recording device that receives signals via a sensor array that are transmitted by the PillCam video capsule as it passes through the GI tract. The data recorder is attached to a belt worn by the patient during the entire examination. In January 2006, the Company launched DR2.0C its most advanced data recorder with added storage capacity.
RAPID Real-Time
This handheld device enables physicians to conduct real-time viewing during the PillCam capsule endoscopy procedure. It also allows physicians to remotely initialize a data recorder to administer the PillCam video capsule to patients at satellite locations. RAPID Real-Time was cleared for marketing by the U.S. Food and Drug Administration in June 2006.
RAPID Software
RAPID 5 is the most advanced version of RAPID software for the PillCam Platform. It enables physicians to compile and review images captured by the next generation PillCam video capsules. RAPID features include the capability to capture still images; adjustable and automatic speed settings; zoom and multi-image views; quick video preview; a tissue color bar; localization; and advanced reporting module. The software also features the RAPID Atlas, which allows comparison of on-screen case images with a library of reference images.
This fifth generation software was cleared by the U.S. Food & Drug Administration in May 2007 and offers new features and powerful diagnostic tools that aid in the reading and interpretation of patient studies. Key features of RAPID 5 include:
• QuickView v5 which allows fast preview of PillCam video images and identifies images that may be of interest to the reviewer;
• The Lewis Score - Provides an approximate measure of mucosal damage. Combined with other clinical parameters such as patient history and previous diagnostic tests, the Lewis Score can be used to monitor the progress of patient treatment;
• RAPID Atlas - Enables the side-by-side comparison of case images with a searchable database of peer-reviewed reference images;