Medtronic has announced new data from the Micra Coverage with Evidence Development (CED) trial which demonstrated significant reduction in complications and reinterventions with the Micra Transcatheter Pacing System (TPS).
Micra TPS, with less than one-tenth the size of traditional pacemakers, is a leadless pacemaker for patients who only require pacing in the right ventricle.
The observational and cohort study evaluated the use, complications, and results of Micra TPS in the US Medicare fee-for-service population.
The trial assessed 6,219 patients implanted with Micra VR TPS and 10,212 patients implanted with traditional TV-VVI pacemakers.
Researchers compared the chronic complications, system reinterventions, as well as all-cause mortality at two-years after implanting the pacemakers.
It was found that the Micra TPS showed a 38% reduction in reinterventions and a 31% in chronic complications compared with standard TV-VVI pacemakers.
No difference was observed in adjusted all-cause mortality at two years compared to the transvenous comparator population, although Micra patients had more comorbidities than transvenous-VVI patients.
Duke University Medical Center cardiac electrophysiology director and medicine associate professor Jonathan Piccini said: “There is considerable evidence supporting the safety and efficacy of leadless pacemakers, but limited data evaluating their long-term outcomes compared to traditional pacemakers in a real-world setting.
“The results from this study further support the connection of a lower risk of complications with leadless pacing compared with traditional transvenous single chamber pacing. These data should help guide physicians as they determine the best pacing options for their patients.”
Medtronic recently announced that over 100,000 patients are using a Micra device across the world.