Micra 

Transcatheter Pacing System

Clinical Evidence

Primary pre-specified 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 twelve months1
    • Yielding an estimated battery longevity on average of 12.1 years

Real-world experience reinforces safety and long-term performance of Micra
(n=1,817)3

  • High implant success rate (99.1%)
  • Low major complication rate through 12 months (2.7%)
    • Low dislodgement rate (0.06%)
    • Low procedure-related infection rate (0.17%)

Lower rate of complications

  • 63% fewer major complications than traditional pacemakers*3

Pacing Capsule


*

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.


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 M, et al. Leadless Pacemaker Implant in Patients with Pre-Existing Infections:  Results from the Micra Post-Approval Registry. Presented at HRS May 2018. Boston, MA.