Paper Clip-Sized Heart Devices Open New Medtronic Market.

http://www.bloomberg.com/news/2014-09-15/paper-clip-sized-heart-devices-open-new-medtronic-market.html

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-basedMedtronic Inc. (MDT), 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.

The Medtronic monitor was approved in the U.S. andEurope 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.

he risks remain rare, including infections where it is inserted and potential failure with the battery, electronic circuits or remote connections.

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.

Fainting Episodes

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.

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.

Ease of Use

“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.”