Clinical Evidence Micra Transcatheter Pacing Systems

Alert Indications, Safety, and Warnings

Primary prespecified safety, effectiveness, and long-term safety objectives were met
(n = 726)1,2

  • 96% of patients experienced no major complications by 12 months follow-up2
    • 0 dislodgements or systemic infections
    • Low (0.4%) revision rate
  • Pacing thresholds remained low and stable pacing thresholds through 12 months1
    • Yielding an estimated battery longevity on average of 12.1 years

Real-world experience reinforces safety and long-term performance of Micra™ VR3

  • Data includes 1,817 enrolled patients at 179 centers in 23 countries 
  • High implant success rate (99.1%)
  • Major complication rate detail through 12 months (2.7%)
    • Perforation rate (0.44%)
    • Infection rate (0.17%); no device-related infection or device removal due to infection
    • Dislodgement rate (0.06%)

Lower rate of complications

  • 63% fewer major complications than traditional pacemakers*3
Kaplan Meier curve chart depicting rate of complications in months from implant
*

Historical cohort comprised of 2,667 patients from 6 trials of commercially available technology. (HR: 0.46, 95% CI: 0.30-0.72; P-value: < 0.001). To adjust for difference in patient populations, propensity matching to a subset of the historical control confirmed a reduction in major complications with Micra VR.

References

1

Reynolds DW, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. February 11, 2016;374(6):533-541.

2

Duray GZ, Ritter P, El-Chami M, et al. Long-term performance of a transcatheter pacing system: 12-Month Results from the Micra Transcatheter Pacing Study. Heart Rhythm. May 2017;14(5):702-709.

3

El-Chami MF, Al-Samadi F, Clementy N, et al. Updated Performance of the Micra Transcatheter Pacemaker in the Real-World Setting: A Comparison to the Investigational Study and a Transvenous Historical Control. Heart Rhythm. December 2018;15(12):1800-1807.