FDA approves swallowable camera-in-a-pill to diagnose bowel problems
Thursday, August 2nd 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ Medicine has caught up to Hollywood: The government approved a tiny camera-in-a-capsule Wednesday that patients can swallow to give doctors a close-up view of their small intestine.
The camera painlessly winds its way through the digestive tract, using wireless technology to beam back color pictures of the gut.
The video pill is made by Israel-based Given Imaging Ltd. and called the M2A Swallowable Imaging Capsule. It's reminiscent of that sci-fi classic ``Fantastic Voyage,'' where a microscopic medical submarine is injected into the body.
``It's very sci-fi, and initially when the people from Given approached me two years ago I didn't believe it'' could work, said Dr. Blair Lewis of New York's Mount Sinai School of Medicine, who tested the video pill on 20 patients and determined it works.
``I have been shown to be wrong _ it is believable and shows tremendous promise,'' Lewis said, estimating that many of the some 25,000 people with internal bleeding of undiagosed causes might be candidates to try the video pill.
It won't completely replace standard intestinal exams, somewhat uncomfortable procedures where tubes fitted with tiny cameras on the end, called endoscopes, are inserted down the throat to look at the small intestine. Indeed, the Food and Drug Administration, in approving the pill Wednesday, warned that it must be used in conjunction with those tests, not as a stand-alone exam.
But endoscopes often can't reach all the way through the 20-foot small bowel, meaning patients left without a diagnosis sometimes had to resort to exploratory surgery.
The video pill offers a pain-free alternative _ and may show doctors some spots they've never been able to see because endoscopes couldn't fit into all the nooks and crannies.
``It's a step forward technologically,'' said Dr. Dan Schultz, FDA's director of abdominal devices. While he cautioned that Given Imaging's video pill so far is limited to just certain patients with small intestine problems, ``this is really the beginning of a long road for this type of technology.''
Don't worry _ the camera is, well, disposable. It is excreted eight to 72 hours after being swallowed, FDA said. Before then, it has beamed its pictures to an external receiver the patient wears on a waistband.
A doctor gives the prescription-only video pill to the patient, who then goes about his day _ walking is encouraged to help the pill move through the system.
A day or so later, the doctor simply downloads the images from the receiver into a computer to see if the pictures allow a diagnosis.
The pill won't replace colonoscopies, those exams that check for colon cancer because the battery doesn't last long enough to get to the large intestine. Nor can it be used for anyone known or suspected to have intestinal obstructions, including problems called fistulas or strictures _ because the pill might get stuck.
A study of 57 healthy people found the video pill can safely pass through the digestive tract. In a study of 20 patients, it was found 60 percent effective in uncovering an intestinal abnormality compared with just 35 percent of abnormalities diagnosed using a traditional endoscope.
The FDA allowed such small studies of the video pill because it is similar to today's endoscopic cameras, just in pill form instead of mounted on a tube.
A U.S. spokesman for Given Imaging said the capsules will be available within 90 days. Doctors who wish to use the video pill will have to buy a $20,000 computer workstation; each capsule is $450.