Given Imaging M2A capsule safe for children

Given Imaging now offers a new Pediatric Accessory Kit to simplify pediatric use of the M2A capsule endoscope. When 12-year-old Carly Taylor first laid eyes on the M2A capsule, she wasn’t sure she could swallow the half-inch, multi-vitamin-sized pod. But …

Given Imaging now offers a new Pediatric Accessory Kit to simplify pediatric use of the M2A capsule endoscope. When 12-year-old Carly Taylor first laid eyes on the M2A capsule, she wasn’t sure she could swallow the half-inch, multi-vitamin-sized pod. But the video-imaging shell – which glides through the digestive tract, transmitting images of the intestines to a portable data recorder – was Carly’s best chance at figuring out what caused her chronic stomach pain.

Eight hours after she swallowed the capsule, Carly’s doctors at Duke University hospital transferred the images of her intestines to a computer, helping them determine that she has Crohn’s disease, a severe inflammatory disease of the bowel that can be controlled relatively easily with medication and steroids.

“To think that it was that simple, after months of invasive procedures, and having Carly crying and screaming in my arms,” tells her father, Phillip Taylor. “Crohn’s is something she may have for the rest of her life. But at least we caught it before it got a good foothold.”

For the Taylors, the capsule examination gave them the answer for Carly’s persistent abdominal pains. For Given Imaging, the Israeli company that created the imaging solution for the gastrointestinal tract – the company name stands for GastroIntestinal, Video, and ENdoscopy – Carly’s successful diagnosis proved that capsule endoscopy is safe and successful for kids as well as adults.

To date, over 65,000 patients worldwide have swallowed the M2A capsule, and more than 140 million Americans currently can be reimbursed by their health plans for capsule endoscopy procedures to diagnose Crohn’s, Celiac disease and other small bowel and small intestine conditions. Now kids aged 10 to 18 can also be diagnosed with the M2A capsule.

The capsule endoscopy procedure was invented by Gavriel Iddan, an electro-optical engineer who spent a good chunk of his career at Israeli military manufacturer Rafael Israel Armament Development Authority, developing guided missile technology. During a sabbatical year in Boston, his neighbor, an Israeli gastroenterologist, challenged him to invent an endoscope that could make its way through the entire gastrointestinal tract. It took about 20 years, but in 1997, Iddan, now the company’s chief technology officer, signed a patent for capsule endoscopy.

The Nasdaq Stock Market-traded company hopes to eventually create imaging solutions for the entire gastrointestinal tract, including the large intestines and colon. With $41 million in sales in 2003, a 40% increase from the previous year, “there are doctors who are ordering capsules every week,” says Sandra Ziv, marketing director at Given.

Since receiving FDA approval in 2001, capsule endoscopy has become standard practice in every gastroenterologist’s practice, with over 10% of gastroenterologists using it in their practices in the U.S., says Dr. Blair Lewis, a gastroenterologist and clinical professor of medicine at Mt. Sinai School of Medicine in New York who participated in clinical trials for he procedure.

“Let’s say you look at someone with Crohn’s disease,” said Dr. Lewis. “These are patients who, for the most part, have symptoms but no demonstrable disease. So they have all these studies – endoscopy, colonoscopy, small bowel series, CAT scans – they have no demonstrable disease, and the doctors are starting to call them crazy. And the capsule shows they have active Crohn’s disease. Well, that’s a phenomenal aid to both the patient and the doctor.”

According to estimates from the Crohn’s and Colitis Foundation of America, there at least one million Americans with inflammatory bowel disease. Children, however, are often diagnosed only when their growth has already been stunted as a result of the disease.

Carly was only six years old when she began complaining about severe stomach pains. But it took four years and countless invasive examinations before the Taylors, who live in Powell, Tennessee, first read about the M2A capsule in an article about the procedure from the prestigious New England Journal of Medicine, written by two British doctors who had performed capsule endoscopy on a patient.

After contacting Given Imaging, the Taylors were told that the procedure was not yet approved for use in the U.S. At the time, the MSA capsule was undergoing clinical trials in Canada, and hadn’t received pediatric approval, or FDA approval, for the procedure.

Like many chronic stomach pain sufferers, Carly had already undergone a battery of invasive gastroenterological tests, including
colonoscopies, endoscopies and Meckel’s scans, as well as an elimination diet in case she was allergic to dairy or wheat products. Every test and diet turned up another dead end.

“I thought it would be fantastic if we could just find someone to do that, to see feet of intestines that other tests couldn’t see,” said Phillip Taylor. “I was convinced that whatever was going on was in the intestines.”

When Carly’s Knoxville pediatrician discovered that Duke University Hospital in Durham, North Carolina, had the capsule endoscopy equipment, the Taylors decided to try the procedure, even though it hadn’t yet received pediatric approval. According to Ziv, it is very common for doctors to use certain new techniques “off-label,” if they are just about to receive FDA approval. In the medical technology market, there are always the “innovators” who are willing to try anything new, she explained, and those who will wait until others have tried it out first.

The hospital was being extremely cautious, since Carly was only their third or fourth patient to undergo capsule endoscopy and was their first
pediatric patient. After repeating the gastric exams, and receiving approval from the hospital board, Carly swallowed the capsule. By the
next day, the Taylors received a call from the gastroenterologist that Carly has Crohn’s disease. She immediately began taking anti-inflammatory medications, which has significantly reduced her stomach pain and given her more stamina and energy.

While Carly may need surgery down the road, her diagnosis has allowed her to live a normal 13-year-old lifestyle.

“They may want to go in there again and see her intestines,” says Phillip Taylor, who likes to take out the capsule every so often just to
marvel at it. “But now her chances of living a normal life are much greater.”