by
Lauren Dubinsky, Senior Reporter | September 01, 2016
Medtronic’s Micra Transcatheter
Pacing System
Medtronic's Transcatheter Pacing System (TPS) has gained a lot attention for being the world’s smallest pacemaker, but the important question is whether it’s safe to use. According to a global clinical trial presented at the 2016 European Society of Cardiology Congress in Rome, it passes the test.
The data revealed that 96 percent of patients did not experience any major complications over the course of 12 months. In fact, the Micra TPS reduced the risk of major complications by almost half compared to conventional systems.
The low rate of complications correlated to a 47 percent decrease in the risk of hospitalization and an 82 percent reduction in the risk of extraction, repositioning and replacement. The complications that were avoided included pneumathoraces, Micra dislodgements and device infections.
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In addition, Micra TPS’ battery life is on par with conventional pacemakers. Based on data of 644 patients using the pacemaker for 12 months, it yielded an estimated average longevity of more than 12 years.
"The Micra TPS has consistently demonstrated strong effectiveness and safety benefits in patients with diverse comorbidities," Dr. Philippe Ritter, principal investigator of the trial and cardiologist at University Hospital of Bordeaux, said in a statement. "All pre-specified safety and efficacy objectives from the trial were met, with consistent findings from early performance, six-month, and 12-month data."
In November 2015, preliminary results of the trial were published in the
New England Journal of Medicine. They showed that Micra TSP was successfully implanted in 99.2 percent of patients and that it met its safety and effectiveness margins.
It was designed with a unique feature that allows it to be permanently turned off. Because of that, it can stay in the body while a new device is being implanted, without causing an electrical interaction.
Micra TPS received CE mark in April 2015 and FDA approval in April 2016. It’s the first and only leadless pacemaker that’s approved for use on 1.5T and 3T full-body MR scans.
