Medtronic Wins Approval for Device to Resynchronize Heart

Medtronic Inc. won U.S. regulatory approval for its Viva device used to resynchronize the beating of the heart and reduce hospitalizations for heart failure.

The permanently implanted device uses an algorithm to coordinate the heart’s 100,000 contractions each day, adjusting to varying demands of the body as the user goes through regular daily activities. The sophisticated system removes the need for doctors to recalibrate the device at regular visits and improves the battery life by 25 percent compared with older models, Minneapolis-based Medtronic said today in a statement.

Significantly more heart-failure patients responded to treatment and they were 21 percent less likely to be hospitalized in the first year than those with older devices, said David Steinhaus, Medtronic’s medical director for cardiac rhythm disease management. The improvements lead to $1,600 in cost savings per patient over the life of the device, he said.

“It’s more cost effective than the older technology, and even the older technology decreases hospitalizations and length of stay,” Steinhaus said in an interview. “These devices are designed to provide optimal therapy for patients, while providing economic benefits through fewer hospitalizations, fewer inappropriate shocks, and increased longevity.”

Patient Improvement

The product cleared for sale by the Food and Drug Administration is the first to make a marked improvement in the number of heart-failure patients who respond to treatment since the synchronization devices were approved more than a decade ago, Steinhaus said. Some doctors don’t refer their patients for evaluations needed to get the devices, and others don’t often implant them, for fear they may not help the patients feel better, he said.

“It’s really the first time we can say we’ve made a difference in response rates,” he said. “Nobody wants to go through the procedure and put this in a patient who isn’t going to feel better, even though we may be helping by stemming the progression of the disease. We expect this to become the standard of care in the United States.” year earlier, the Minneapolis-based company said in a statement

Medtronic declined less than 1 percent to $47.70 at the close in New York. The shares have increased 25 percent in the past 12 months.

Medtronic is the world’s biggest maker of heart-rhythm devices.

(Updates Medtronic trading in seventh paragraph.)
    Before it's here, it's on the Bloomberg Terminal. LEARN MORE