Receive our newsletter – data, insights and analysis delivered to you
  1. News
August 30, 2021

Medtronic reports positive CED trial data for Micra TPS leadless pacemaker

The trial assessed patients implanted with Micra VR TPS and with traditional TV-VVI pacemakers.

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.

Content from our partners
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy