Dr. Gavriel J. Iddan is a mechanical engineer who worked on imaging devices for Rafael, an Israeli government-owned research and development company that works with the Jewish state’s Ministry of Defense. Some 20 years ago, he worked on different types of electro-optical equipment, some of it related to guided missile systems.
Today, Iddan is taking aim at a new objective: human disease. He’s hard at work improving the ingestible video camera — yes, an ingestible video camera — that he invented in 1994. As the chief technology officer of the five-year-old medical-device company Given Imaging in Yokneam, Israel, he has been enhancing the diagnostic abilities of the camera, which transmits images from a patient’s small intestine to an external recorder. Like a missile sending video pictures along its trajectory, the process mirrors Iddan’s defense research.
“Dr. Iddan realized he could make an ingestible ‘missile’ that would transmit images as it passes through the small intestine,” Given’s president and CEO, Gavriel Meron, said by telephone from Israel.
Given’s swallowable capsule — trademarked as the M2A Capsule Endoscope (M2A stands for mouth-to-anus) — has revolutionized the diagnosis of small-intestine disorders, which are difficult to visualize via X-rays or other, more invasive endoscopic methods, American gastroenterologists say. (Endoscopies, which are invasive, allow doctors to examine the digestive tract via a thin tube with a camera lens, but do not allow physicians to see the majority of the small intestine; X-rays often cannot detect bleeding on the walls of the small intestine.)
The camera pill, however, is noninvasive, easy to swallow — at 11 mm by 26 mm, it looks like a bulky vitamin — and locates problems other methods cannot, experts say. “It allows us to see the interior of the small intestine with great clarity, not just shadows on an X-ray,” said Dr. Asher Kornbluth, a gastroenterologist in Manhattan who has used the M2A.
Patients pop the camera capsule — which contains a tiny lens, video camera, light, battery, antenna and transmitter — in their mouth in the morning. Peristalsis, the natural coordinated muscle contractions that move food, helps the device make its way through the esophagus, stomach and small intestine.
For eight hours, the camera takes internal pictures at a rate of two frames per second, sending them to a CD-player-sized receiver worn on the patient’s hip. After eight hours, the patient returns to the doctor, who downloads nearly 60,000 images from the receiver to a computer. Given software helps the doctor review the video stream for abnormalities. The patient later excretes the capsule, which is not reusable.
“The only problem with wearing the recorder,” said a 76-year-old man from Queens Village who underwent the procedure and asked that his name not be used, “is that… someone might mistake you for a terrorist carrying a bomb…. But if you wear a jacket, you’re all right.”
In July, the Food and Drug Administration gave the firm permission to sell the camera-pill as a first-line diagnosis in the evaluation of small intestine problems. In late October, the FDA gave clearance for the device’s use in children between the ages of 10 and 18. Both approvals followed the FDA’s August 2001 approval of the capsule device as a secondary method to diagnose small bowel disease, after X-rays and other kinds of endoscopy. In October of that year, the company went public.
Given’s Meron said that the FDA gave the company the July go-ahead because analyses of data from 691 patients in 32 studies revealed that the capsule enabled doctors to diagnose a variety of small intestine problems in about 60% of the patients. All the other technologies combined could find the source of the problem in only 40% of the patients. The pediatric approval was based on a study of 30 young patients.
The device can diagnose irregular bleeding, tumors, Crohn’s disease, polyps and other small-intestine abnormalities, doctors say. The symptoms of Crohn’s disease, which tends to affect Jews of Ashkenazi descent disproportionately, include small-intestine inflammation, pain, diarrhea and sometimes rectal bleeding.
But the device cannot treat the problems it finds, doctors point out, and drugs, surgery or other procedures are still necessary to remove a tumor or stop bleeding.
In about 1% of patients, particularly those who have Crohn’s disease, the capsule might get stuck at a stricture or an obstruction in the small intestine. The company has developed a capsule that dissolves if it hits a barrier, which is now available in Europe. Patients who wear pacemakers also should not use the capsule.
The company continues to improve the software that allows doctors to analyze the video images. It recently improved the algorithms that highlight areas where there might be bleeding and developed a two-window system that allows physicians to compare tissue.
Given plans to develop the capsule to diagnose problems in the stomach and in the esophagus, a site of the common gastroesophageal reflux disease.
Health insurance companies usually will reimburse for the device’s use, based on FDA approval and published medical studies, Nancy Sousa, Given corporate vice president, said from the company’s American headquarters in Norcross, Ga. The firm, Sousa said, is working with insurers to widen coverage.
At the October meeting of the American College of Gastroenterology in Baltimore, Md., the company reported findings about the device’s ability to help doctors detect celiac disease, a sensitivity to wheat-protein gluten that results in the destruction of the lining of the small intestine. Other research highlighted its potential cost-effectiveness to the healthcare system.
“You use the device, you find something, you do something,” said Dr. Alan Buchman, a gastroenterologist and associate professor of medicine at Northwestern University’s medical school in Chicago who was not involved in the cost-effectiveness research. “You can also use the device and find something [for which] there is no treatment. However, knowing the diagnosis prevents doing other unnecessary procedures that can cost money.”
As of June, some 600 hospitals and medical offices in the United States offered the capsule technology to patients. Some 32,000 Americans have gulped down the camera-pill, along with another 20,000 people in the rest of the world. The device is available in 55 countries.
The Capsule Endoscope System, however, is expensive; about 10 million Americans have insurance coverage that will cover anything other than the detection of bleeding. Each disposable camera costs $450, and doctors and hospitals spend $17,500 on each workstation needed for the procedure and $5,450 for a recorder.
About 140 million Americans have health insurance policies that provide reimbursement when the device is used to diagnose gastrointestinal bleeding, according to Meron.
For now, using the device is not economically feasible for some doctors. “The reimbursement doesn’t really cover the amount of time needed to do the analysis,” said Dr. Jerome Waye, a gastroenterologist in New York City. “A gastroenterologist can do two colonoscopies [endoscopies that look for abnormalities in the large intestine, which are more highly reimbursed by insurance] in the amount of time it takes to study the images.”
But, he added, “we are not doing capsule endoscopy to make money. We do it as part of our commitment to our patients. It is a good technology. Next-generation devices will even be better.”
Robin Eisner is a freelance health writer who lives in New York City.