Medtronic‘s (NYSE:MDT) entry into the micro-sized leadless pacemaker market has met its primary safety and effectiveness endpoints with “wide margins,” the company said today.
The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.
Results from the trial were presented at the American Heart Association’s scientific sessions meeting this week and published in the New England Journal of Medicine, Medtronic said.
“We are extremely pleased with the remarkably successful implant rates and safety profile of the Micra pacemaker, including the absence of device dislodgments. We are especially confident in these results because the trial included patients with serious comorbidities from 19 countries on five continents around the world. The Micra TPS not only met its trial endpoints, but also provided a significant reduction in healthcare utilization due to fewer major complications compared to conventional pacing systems, which is particularly important in an era of value-based healthcare,” principal investigator Dr. Dwight Reynoldsof the University of Oklahoma Health Sciences Center said in a press release.
Fridley, Minn.-based Medtronic said that 99.2% of patients in the trial were successfully implanted with the device. A total 96% of 725 patients experienced no major complications, which Medtronic said is 51% less than is seen in patients with conventional pacing systems.
Cardiac injuries occurred in 1.6% of patients, complications at the groin site in 0.7% and pacing issues in 0.3%. Medtronic said there were no dislodgments, no systemic infections and a 0.4% rate of system revisions.
“This is an exciting time for patients who need pacing therapy, as the Micra technology delivered substantial value in the trial through a less invasive procedure with fewer complications, compared to conventional devices. We anticipate this excellent clinical performance will help reduce healthcare costs and provide economic benefit as well,” cardiac rhythm and heart failure brady biz veep Brian Urke said in prepared remarks.
In a comparison of the Micra TPS study and a historical control group of more than 2,500 patients, the company said the patients in the Micra trial were older and had more comorbidities, but experienced fewer complications.
After 6 months, 98.3% of patients showed low and stable pacing thresholds, which Medtronic said yielded a projected average longevity of more than 12 years for the device.
Micra patients reported 54% fewer hospitalizations and 87% fewer system revisions compared with historical control groups, Medtronic said.
Medtronic said it has enrolled 744 patients in the ongoing trial evaluating the safety and efficacy of the device.
In April, Medtronic said it won CE Mark approval in the European Union for the Micra, the company said today, touting it as the world’s smallest pacemaker.
The CE Mark was granted based on 3-month results from the 1st 60 patients enrolled in Medtronic’s Micra TPS trial, the company said.