Paper Clip-Sized Heart Devices Open New Industry Markets

A heart monitor the size of a paper clip may help keep Fred Schakel alive.

Schakel, a 46-year-old Indiana dairy farmer, had a stroke in November, just when he thought he was in the best shape of his life. Doctors couldn’t identify a reason, so Schakel now wears the tiny monitor, dubbed the Reveal Linq, inserted under the skin of his chest as he goes about his daily life.

The $5,000 device records heart abnormalities that can occur monthly or crop up less than once a year, and is in constant electronic contact with Schakel’s doctor’s office. Made by Minneapolis-based Medtronic Inc., it’s part of a drive to develop consumer-friendly heart devices for an aging and image-conscious boomer population that don’t require troublesome and inconvenient electric wires and halters.

The new monitor “is a game-changer in this niche field,” said John Day, the medical director at Intermountain Health Care’s heart rhythm services in Murray, Utah. “From the patient’s standpoint, it’s a tremendous win.”

It also adds a new horizon for a device industry that’s been battered by recalls and questions about safety and overuse, leading to years of falling sales. Medtronic isn’t alone with its strategy. St. Jude Medical Inc. purchased Nanostim Inc. last October to acquire its miniature pacemaker.

Medtronic fell less than 1 percent to $64.95 at 4 p.m. New York time, after gaining 21 percent in the last 12 months.

Fastest Growing

The Medtronic monitor was approved in the U.S. and Europe in February. Its ease of use, coupled with an ability to transmit a large amount of data without much effort from the patient or doctor, has made it into one of the company’s fastest-growing products, Medtronic executives said. They declined to provide precise sales figures.

“In June we thought this market, which was near nothing before, could be a half-a-billion dollars in a three-year time frame,” Medtronic Chief Financial Officer Gary Ellis said in a telephone interview. “The reality is that we are going to get to a half-a-billion market much quicker than we expected. It’s going to be a big driver in the years to come.”

Medtronic began its miniaturization initiative a decade ago, purposefully keeping it separate from its conventional research group because officials knew it had the potential to disrupt the company’s current product pipeline.

First Out

The Reveal Linq is the first product to emerge from the program. A pacemaker now in final human trials may be the second. That device is small enough to be threaded into the heart via an artery, according to Medtronic, and it has the battery power inside it to be left there for a decade.

“Our engineers have gotten very good at being very stingy with power,” said David Steinhaus, the medical director for Medtronic’s heart rhythm unit. “We have been able to shrink down the size of the electronics and make the power consumption of those chips a lot less.”

While U.S. baby boomers are one target for the miniature devices, their simplicity may also open a broad swatch of the world where patients could benefit from the technology but doctors don’t have the training to implant the older, more complex models.

The Reveal Linq monitor has been embraced by doctors and patients with certain hard-to-diagnose conditions, according said Intermountain’s Day. The risks remain rare, including infections where it is inserted and potential failure with the battery, electronic circuits or remote connections.

Pooling Blood

While an erratic heart beat may be infrequent, just one episode is enough for pooling blood to form a clot that can move to the brain and cause a stroke.

A slowdown or pause can cause fainting, leading to head injuries, car crashes and fear.

“The real benefit of implantable monitors is to spot something that doesn’t happen frequently, maybe once or twice a year, especially for someone who is passing out,” Day said.

Unexplained episodes of fainting affect about 1 million Americans each year. The trigger can be a drop in the heart rate, which is easily controlled with an implanted pacemaker to ensure a proper rhythm. It can also be caused by other, non-heart related conditions and metabolic problems, making it difficult in some cases to pinpoint the cause.

The fastest growing area of use is in people with cryptogenic strokes, those such as Schakel who suffer a stroke with no clear cause.

Erratic Rate

While doctors can pinpoint causes for about two-thirds of the 800,000 strokes in the U.S. each year, many of the rest may be linked to erratic heart rates, a condition known as atrial fibrillation. Once the condition is diagnosed with monitoring, the risk can be cut with blood thinners or a procedure to fix an electrical defect.

To make the tiny products, Medtronic’s engineers consulted with Swiss watchmakers, known for the precision and small size of the watch movements.

“We knew we could make a tiny device, but we didn’t know if we could do it in a high volume production facility,” Steinhaus said. “We had to learn to do things small, with specialized machinery. Human hands aren’t able to do it.”

Micra, the pacemaker that is the company’s second product from the initiative, doesn’t have the traditional wires used to connect to a canister that houses the battery and electronic circuitry. The company is still studying it to identify possible complications, which may include difficulty inserting it through the femoral vein, problems latching it onto the heart wall, infection or a breakdown in its operation.

Less Power

The pacemaker, expected to hit the market in Europe within a year and in the U.S. by 2017, uses less power when turned on than a mobile phone uses when it’s off, Steinhaus said.

“Anything that can make it easier for the physician to implant these devices, reduce complications and do it in a cost effective manner -- check,” said Joanne Wuensch, an analyst at BMO Capital Markets in New York. “That’s the wave of the future. These are both really important evolutions in terms of how technology is being delivered.”

Schakel, the farmer from Wheatfield, Indiana, hasn’t had any heart problems since his Reveal Linq was implanted in May, he said by telephone. He also hasn’t had another stroke.

Reassurance from the constant monitoring has helped him return with confidence to his normal, active life on the farm.

“No news is good news in this situation,” he said. “I am fully active again as far as exercise and work. I haven’t had any events.”

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