Primary prespecified safety, effectiveness, and long-term safety objectives were met
(n = 726)1,2
Real-world experience reinforces safety and long-term performance of Micra™ VR3
Lower rate of complications
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.
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.
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.
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.