Medtronic Seeks Approval For Pill-Sized Pacemaker
Medtronic’s latest pacemaker could be a game-changer after a study published Monday in the New England Journal of Medicine said patients using its new heart-monitoring device had significantly fewer complications compared to those with traditional pacemakers.
At less than one-tenth the size of traditional pacemakers (or roughly the size of a large vitamin), Medtronic’s Micra Transcatheter Pacing System (TPS) was successfully implanted into more than 99 percent of the 725 patients in its trial. Only 4 percent experienced major complications from the Micra TPS, which is attached inside the right ventricle of the heart. (Traditionally, pacemakers have required the use of wires, known as “leads,” to shock the heart if its beat slows.)
In a statement, Dwight Reynolds, M.D., the trial principal investigator for the study, said he felt “especially confident” in the results gathered, particularly because the testing pool spanned 19 countries and included patients with a simultaneous presence of two chronic diseases, known as comorbidities.
“The Micra TPS not only met its trial endpoints,” he said, “but also provided a significant reduction in healthcare utilization due to [51 percent] fewer major complications compared to conventional pacing systems, which is particularly important in an era of value-based healthcare.”
After meeting its global safety and effectiveness standards, Dublin-based Medtronic hopes to soon gain U.S. Food and Drug Administration approval for the Micra TPS. To date, the device has only been approved for use in Europe.
“We anticipate this excellent clinical performance will help reduce healthcare costs and provide economic benefit as well,” said Brian Urke, vice president of the Cardiac Rhythm and Heart Failure’s Brady business at Medtronic.
In a company release, Medtronic said it would continue trials of the Micra TPS at its 56 research centers, which span 19 countries on five continents.
The most recent study from the American Heart Association found that roughly 3 million people worldwide use pacemakers, and each year 600,000 more pacemakers are implanted.