Redefined patient experience
No chest scar or bump, fewer post-implant activity restrictions.
Eliminated pocket-related complications
Infection, hematoma, erosion.
Eliminated lead-related complications
Fractures, insulation breaches, venous thrombosis and obstruction, tricuspid regurgitation.
| Parameter | Micra AV⁵ | Micra VR⁶ |
|---|---|---|
| Volume | 0.8 cc | 0.8 cc |
| Mass | 1.75 g | 1.75 g |
| Battery longevity | 8–13 years† | 12 years‡ |
| FlexFix™ nitinol tines | Yes | Yes |
| Capture Management™ | Yes | Yes |
| Accelerometer-based mechanical atrial sensing | Yes | N/A |
| Accelerometer-based rate response | Yes | N/A |
| CareLink™ remote monitoring14 | Yes | Yes |
| MRI SureScan™ | 1.5 T & 3 T | 1.5 T & 3 T |
| Pacing mode | VVI, VVIR, VOO, OVO, VDD, VDI, ODO, OFF | VVI, VVIR, VOO, OVO, OFF |
CareLinkTM remote monitoring
For AV block patients5
One device solution
New, integrated circuitry capable of sustaining new AV synchrony functionality2
Minimal hardware & complexity2
11 new algorithms,2 including:
• AV Conduction Mode Switch
• Rate Smoothing
• Activity Mode Switch
Accelerometer detects mechanical atrial activity and uses this information to deliver AV synchronous ventricular pacing2
Delivers an estimated average battery longevity of 8-13 years, dependent on patient’s degree of AV block5,7
99% implant success in Micra™ VR* clinical studies
Micra™ AV and Micra™ VR use the same implant tools for deployment and delivery.
Micra™ AV
algorithm performance14
AccelAV: Micra™ AV
is a proven therapy for
patients with AV block13
Micra™ VR
procedural performance10,12
Coverage with Evidence
Development (CED) study
– three-year outcomes17
Micra™ clinical
evidence
Educational resources on Medtronic Academy
Footnotes
*
The single chamber Micra™ Transcatheter Pacing System is being described herein as Micra™ VR in order to distinguish it from Micra™ AV product. When information in this document related to both Micra AV and VR, “Micra™ Transcatheter Pacing Systems” is used to represent the portfolio of devices. Micra AV real world data not yet available.
†
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.12
References
1
Nippoldt D, Whiting J. Micra Transcatheter Pacing System Device Volume Characterization Comparison. November 2014. Medtronic data on file.
2
Medtronic Micra™ AV MC1AVR1 Reference Manual. March 2020.
3
Udo EO, Zuithoff NP, van Hemel NM, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. May 2012;9(5):728-735.
4
Williams E, Whiting J. Micra Transcatheter Pacing System Size Comparison. November 2014. Medtronic data on file.
5
Medtronic Micra™ AV MC1AVR1 Device Manual. March 2020.
6
Medtronic Micra™ MC1VR01 Clinician Manual. April 2015.
7
Pender J, Whiting J. Micra AV Battery Longevity. January 2020. Medtronic data on file.
8
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.
9
Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. February 11, 2016;374(6):533-541.
10
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.
11
Lopez-Liria et al, Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study. Int. J. Environ. Res. Public Health 2020.
12
El-Chami, M.F. et al. (2022) Abstract 13220: Real-world analysis of the electrical performance and projected longevity of leadless ventricular pacemakers, Circulation. Available at: https://www.ahajournals.org/doi/10.1161/circ.146.suppl_1.13220 (Accessed: November 16, 2022).
13
Chinitz LA, El-Chami MF, Sagi V, et al. Ambulatory AV synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study. Heart Rhythm.Published online September 5, 2022.
14
Steinwender C, Khelae SK, Garweg C, et al. Atrioventricular synchronous pacing using a leadless ventricular pacemaker: Results from the MARVEL 2 Study. JACC Clin Electrophysiol. 2020;6(1):94-106.
15
Ritter P, et al. Long-Term Performance of a Transcatheter Pacing System: 12-month results from the Micra Global Clinical Trial. LBCT presentation at ESC 2016; Rome, Italy.
16
Leick, A. Micra “Largest Reach” supporting data June 2022. Medtronic Data on file.
17
Crossley G. et al, J Cardiovasc Electrophysiol. 2023 Apr;34(4):1015-1023.
18
Akatsu, Susumu. 160,000 Micra Patients Implanted. November 2022. Medtronic Data on File.
19
Eggen, M. et al. Design and evaluation of mechanism for a transcatheter pacemaker. IEEE, 2015.
20
Grubac, V, et al. Analysis of the Micra fixation mechanism use conditions and holding energy requirements. Presented at EHRA Europace 2014 (Abstract 16-56).
21
Pacing Clin Electrophysiol . 2018 Dec;41(12):1606-1610. doi: 10.1111/pace.a novel fixation 13529. Epub 2018. Nov. 11
22
Sperzel et al. Benefit of enhanced ventricular capture management in automated pacemaker. Europace Supl 2003.
23
Rosenthal LS et al. Factors Influencing Pacemaker Generator Longevity: Results from the Complete Automatic Pacing Threshold Utilization Recorded in the CAPTURE Trial. PACE 2010.
24
Ando et al, Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study. J Arrhythmia 2011; 27: 307–313
25
El-Chami et al, Leadless vs. transvenous single-chamber ventricular pacing in the Micra. European Heart Journal, 2022.
26
Alexander, Leick. 175,000 Micra patients implanted. March 2023. Medtronic Data on File.
27
The value of leadless pacing. Global Business Media Special Report, 2022
28
Garweg et al, Correlation Between AV Synchrony and Device Collected AM-VP Sequence Counter in Atrioventricular Synchronous Leadless Pacemakers: A Real-World Assessment. J Cardiovasc Electrophysiol. 2023 Jan;34(1):197-206.
29
Omdahl et al, Right ventricular anatomy can accommodate multiple Micra transcatheter pacemakers. Pacing Clin. Electrophysiol, 2016.
30
Haeberlin et al, Evolution of tricuspid valve regurgitation after implantation of a leadless pacemaker: A single center experience, systematic review and meta-analysis. J Cardiovcasc. Electrophysiol, 2022.
31
Roberts et al, A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry, Heart Rhythm, Vol 14, No 9, September 2017
32
Soejima et al, A Leadless Intracardiac Transcatheter Pacing System, NEJM 2016.
33
Steinwender et al, Atrioventricular synchronous pacing using a leadless ventricular pacemaker. JAAC: Clinical Electrophysiol, 2020.
34
Lloyd et al, Rate adaptive pacing in an intracardiac pacemaker. Heart Rhythm, 2017.
35
Henderson M, Palkert D., Yoon S., Micra Evolution Battery Report. April 2020. Medtronic data on file.