Medtronic's tiny implanted cardiac monitor gets approval

It's a device that even Medtronic Inc. officials admit is a little James Bond. But the tiny wireless cardiac monitor that doctors slip just beneath the skin with a syringe-like device is expected to make a very real impact for doctors and patients.

Called the Reveal Linq ICM, the tinier-than-a-battery device can tell doctors if fainting or dizziness is because of an abnormal heart rhythm. "It takes 30 seconds and you're done," Pat Mackin, president of Medtronic's cardiac rhythm disease management business, said of the time it takes to implant.

Fridley-based Medtronic on Wednesday announced the global launch of the device, about one-third the size of a AAA battery in volume and about 80 percent smaller than similar devices on the market. The company has received regulatory approval in the United States and Europe. The device is inserted through a 1-centimeter incision. There is no need for general anesthetic, and it continuously and wirelessly monitors the heart for up to three years.

"There is a huge void for this type of technology," said Dr. Rod Passman, professor and associate director of cardiac electrophysiology at the Northwestern University Feinberg School of Medicine in Chicago. "This device is good at picking up all abnormal rhythms of the heart."

Indicated for use as a diagnostic tool for people suffering from unexplained fainting, dizziness, palpitations or chest pain, Reveal also will help doctors determine if a patient has atrial fibrillation, Passman said. The abnormal heart rhythm, connected to stroke, "can be very intermittent and asymptomatic. We usually only check for a few days and rely on patients to tell us what's wrong," he said. "We miss it most of the time. We have been practicing this area of medicine in darkness."

Reveal Linq will automatically download its data via satellite every evening through Medtronic's Carelink network, Passman said. Doctors will be able to program it to alert them to any specific abnormalities.

"This is as close to the truth as we can hope to get," he said of the diagnostic power of the device.

"There are several problems in everyday clinical cardiology, fainting, other issues," he said. "It can be tough to find out what happened and why it happened. Patients may come back in a month or they may never come back."

Schwartz said he had a research nurse who had fainting spells. She was 38 years old and apparently healthy. Doctors implanted the Reveal Linq's predecessor, the Reveal XT. Several months later, after she fainted at work, the device showed the woman's heart had stopped for 12 seconds. She now has a pacemaker and is doing fine, Schwartz said.

"It's a very good thing," he said of Reveal Linq. "It's going to help us."

The fact that the device is tiny, is quick and easy to implant and cannot be seen will help convince patients to use it, Mackin said. Creating diagnostic technology that is smaller and smaller, yet powerful, is an increasing priority, he said. In-house Medtronic engineers have worked "for many years" to develop the Reveal Linq, he said.

"This was a totally internal effort," Mackin said. "This is a solution to health care. It is a diagnostic device that can diagnose problems at a lower total cost for the health care system."

"This will be a very big product for the future," he said of the tiny device.