CAPSULE ENDOSCOPY - FREQUENTY ASKED QUESTIONS

Thursday, August 30, 2001

Q. What is the size of the capsule?

A. The dimensions of the capsule are 11 mm x 26 mm and it weighs about 4 grams.

Q. What is the capsule made of?

A. The capsule is made of specially sealed biocompatible material that is resistant to the digestive fluids throughout the GI tract.

Q. What components comprise the "wireless endoscopy" technology?

A. There are three components: the ingestible M2A™ Capsule, the size of a large vitamin, which is made up of a miniature color video camera, a light source, batteries, a miniature transmitter, and an antenna; the Given® Data Recorder including sensor array which is worn about the waist during the examination; and the RAPID™ Workstation which processes the data downloaded from the Given Data Recorder into a short video film clip and presents other relevant GI parameters.

Q. How does this tiny capsule encoscope work?

A. The disposable M2A™ incorporates a light source, a miniature color video camera, battery, antenna and a radio transmitter. The image of the intestine is captured by the video camera and transmitted by radio frequency to an array of sensors worn around the patient's abdomen. The signals are recorded digitally on a device, which resembles a portable "Walkman™" carried on the belt. The patient removes the belt and data recorder after approximately eight hours (or after detecting that the capsule has been excreted - if earlier) and returns the belt and recorder to the clinic. At the clinic, the images are downloaded from the recorder onto the RAPID™ Workstation. The doctor can then examine the video (Patient Rapid Report) to look for abnormalities.

Q. How does the capsule move through the gastrointestinal tract?

A. A patient ingests the capsule with a sip of water. It moves through the intestinal tract by the natural contraction and relaxation of the gastrointestinal tract called peristalsis. The capsule is excreted naturally.

Q. Do doctors see the pictures of the GI tract and its environs on a TV screen? Are these still pictures or "real time" pictures?

A. After the patient returns the Given® Data Recorder to the physician and the data has been downloaded from the recorder to the RAPID™ software performs advanced image and data processing on the video and data. It transforms them into a video that may be viewed and reviewed by the physician offline at a rate faster or slower than real-time.

Q. What happens to the M2A™ after the 24 hours or so that it takes for it to run through the patient's gut? Does it pass through the body and out? Is it somehow absorbed?

A. The M2A™ moves naturally through the gastrointestinal tract and is excreted naturally, without any sensation whatsoever. The M2A™ Capsule is disposable, so patients are not required to return the device to the physician. It is NOT absorbed in the body!

Q. Are there any side effects?

A. To date, no side effects have been found with use of the capsule according to Given's guidelines.

Q. Swallowing the capsule has been compared to "swallowing an aspirin." Is it that easy and painless?

A. Yes. It seems that the most important factor in ease of swallowing is the lack of friction. The capsule is very smooth, enabling it to slip down the throat with just a sip of water. After swallowing the M2A™, the capsule passes through the GI tract with absolutely no sensation.

Q. How were the engineers able to put what is essentially a television camera in a capsule?

A. The capsule is made possible by the development of Complementary Metal Oxide Semiconductor (CMOS) video imaging chips that require far less power than more conventional Charge-Coupled Device (CCD) chips.

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Contact: Anne Tewksbury 480-301-4368

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