Given Imaging

Home

Given Imaging
2 Hacarmel St. New Industrial Park POB 258
Yoqneam 20692
Tel: +972 (4) 909 7777
Fax: +972 (4) 959 2466
contact: info@givenimaging.com
website: www.givenimaging.com
Overview of Products
Since 2001, Given Imaging has provided innovative tools to help physicians accurately diagnose gastrointestinal disease, improving patient outcomes. From our PillCam family of products, which give physicians an inside look at the GI tract, to the Bravo pH monitor, which provides the most accurate, patient-friendly option for GERD diagnosis, all of our tools are designed to help you make a correct diagnosis in a patient-friendly manner. Please click on the menu bar to your left to learn more about each of our products.
Related categories: Medical Suppliers

PillCam Capsule Endoscopy
PillCam Capsule Endoscopy
Given Imaging’s product line is based around its flagship technology platform. The PillCam Platform is used on an outpatient basis and consists of several components including disposable PillCam video capsules, the Given Workstation and RAPID software.

The PillCam video capsule is an ingestible pill the size of a large vitamin. It is equipped with a miniature video camera inside that is designed to capture color images from inside the body. As it moves through the GI tract it wirelessly transmits the images through sensor array secured with adhesive pads to the patient’s abdomen in the case of PillCam SB and the chest with PillCam ESO. The images are stored in a data recorder attached to the patient’s waist. At the completion of the procedure the data recorder is removed from the patient and then connected to the Given Workstation. The Company’s proprietary RAPID software is installed on the computer workstation and enables a physician to review the images and makes a diagnosis based on the findings.

PillCam ESO
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 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.

Benefits & Risks
Benefits of the Bravo Catheter-free pH Monitoring System
Designed for Greater Accuracy
Since patients are able to maintain their regular diet and activities, pH data more accurately reflects patient's physiologic condition.

Increased Clinical Information
The Bravo pH Monitoring System provides 48-hours of pH data - double the amount of data captured in a conventional catheter-based test.

Enhances Patient Comfort
The catheter-free system minimizes throat and nasal discomfort associated with traditional pH catheters.

Increases Patient Convenience
The small pager-sized receiver allows patients freedom to carry out their normal activities.

Easy to Use
The user-friendly PC based Bravo pH Analysis Software simplifies pH data analysis.

Benefits to Clinicians
  • Reports the percentage of time that esophageal pH is less than 4 for the duration of the study as well as separately for supine and upright periods
  • Reports the number of reflux episodes, Johnson and DeMeester score, DeMeester score, symptom association probability, symptom index and reflux area
  • Provides add-on modules to conduct more in-depth pH studies using the Advanced pH Analysis Application

Bravo Procedure
Bravo pH Monitoring Procedure
The catheter-free Bravo pH Monitoring System is revolutionizing pH testing with a capsule that collects pH data and transmits it via radio frequency telemetry to a small external pager-sized receiver worn by the patient.

Benefits to Clinicians
  • Easy to place following endoscopy — adding only minutes to the procedure
  • Gathers 48 hours of pH data — providing the additional data needed for an accurate assessment
Patient Friendly
  • Allows patients to maintain regular diet and activities
  • Minimizes throat and nasal discomfort associated with conventional catheter-based pH systems
  • Eliminates social embarrassment that accompanies traditional pH testing with no visible indication that pH test is taking place
48 Hours of pH Data
  • Allows physicians to extend pH data collection to 48 hours — 24 hours beyond the recording capability of conventional catheter systems
  • Detects more abnormalities than 24 hours alone providing the additional data needed for an accurate GERD assessment
  • Increases number of recorded symptoms associated with reflux events significantly when recording time is extended beyond 24 hours1
  • Increases likelihood of documenting relationships between atypical symptoms and reflux events with 48-hour monitoring period, said a study published in The American Journal of Gastroenterology2
Easy Placement Procedure
  • Easily placed following endoscopy or manometry adding only minutes to the procedure
Step 1.
Position the capsule in the esophagus
Step 2.
Apply suction
Step 3.
Attach capsule
Step 4.
Remove delivery system
Step 5.
Begin transmitting pH data to receive

References
  1. "Symptom Association Tests Are Improved by the Extended Ambulatory pH Recording Time with the Bravo Capsule" Ray E. Clouse, Chandra Prakash, Laura R. Haroian, DDW 2003

  2. "Ambulatory Esophageal pH Monitoring Using a Wireless System" John E. Pandolfino, M.D., Joel E. Richter, M.D., Tina Ours, RN, Jason M. Guardino, M.D., Jennifer Chapman, M.D., and Peter J. Kahrilas, M.D., The American Journal of Gastroenterology, Vol. 98, No. 4 2003
Copyright® 2010 Business Briefings, Ltd. All rights reserved.
Touch Gastroenterology is for informational purposes and should not be considered medical advice, diagnosis or treatment recommendations.