Micra Pacemakers | 合法醫療器材資訊網

TheminiaturizedMicraAVandMicraVR*transcatheterpacingsystems(TPS)aretheworld'ssmallestpacemakers1forbradyarrhythmiamanagement,delivered ...

The single chamber Micra™ transcatheter pacing system is being described herein as Micra™ VR in order to distinguish it from the dual chamber (VDD) Micra™ AV product. When information in this document relates to both Micra AV and VR, “Micra™ transcatheter pacing systems” is used to represent the portfolio of devices.

Use conditions include: 8 years = 100% VDD pacing, 60 bpm, pacing threshold 1.5 V, impedance 500 Ω, pulse width 0.24 ms. 13 years = 15% VDD pacing, 70 bpm, pacing threshold 1.5 V, impedance 600 Ω, pulse width 0.24 ms.

Use conditions included: median pacing 53.5%, median pacing threshold 0.50 V, median impedance 543 Ω; 89% of patients with > 10-year projected longevity; 99% of patients with > 5-year longevity.5