MicraTM AV is a proven therapy for patients with AV block1

  

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Ambulatory AV synchronous pacing over time using a leadless ventricular pacemaker:
Primary results from the AccelAV study

Larry A. Chinitz, M.D., FHRS, Mikhael F. El Chami, M.D., FHRS, et al.

Results1

Sustained resting AV synchrony

85.4% and stable through three months

Improved ambulatory AV synchrony

82.6% with optimized programming

No upgrades through three months

No major complications due to pacemaker syndrome

Improved ambulatory AV synchrony with optimized programming1

micra AccelAV

Podcast

Listen now to the podcast on the Micra AccelAV study from Alphons Vincent, Medtronic Medical Affairs Director for Western Europe. 

Spotify | Apple Podcasts

Purpose1

To report on the performance of the Micra AV leadless ventricular pacemaker with accelerometer-based algorithms that provide AV synchronous pacing. 

Study design1

Prospective, single-arm, multicenter, global study

- 152 subjects from 20 centers in the U.S. and Hong Kong were implanted with a Micra AV

– 54 with complete AV block and normal sinus function (primary analysis cohort)

- 20 with complete AV block, normal sinus function, and optimized programming (Optimized sub-study cohort)

 

Micra VR and AV leadless pacemakers2,3

micra AccelAV
micra AccelAV
micra AccelAV

Latest clinical evidence and guidelines

micra AccelAV
EHRA/HRS/LAHRS/APHRS position paper

which aims to review the underlying evidence, provide practical considerations for optimal use and patient selection for laeadless and extravascular CIED’s.

Position paper CED 2023
CED study : 3-year follow-up

Read the Micra™ CED study published in the European Heart Journal. Real-world study showing the safety and efficacy of the Micra leadless VVI pacemaker vs transvenous pacemakers.

micra AccelAV
ESC 2021 guidelines

ESC Guidelines now recommend leadless pacing for defined patient populations.4

 

*

Includes independently published manuscripts not sponsored by Medtronic.

References

1

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.

2

Leick A. “Largest Reach” supporting data. June 2022. Medtronic Data on file

3

Clementy N, et al. Early Experience with a Leadless Ventricular Pacemaker Providing Atrioventricular Synchronous Pacing in the Real-World Setting: Results from the Micra AV Post-Approval Registry. Presented at HRS 2022 Scientific Sessions. April 30, 2022. San Fransico

4

Glikson, M. et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. October 2021. European Heart Journal.

5

Nippoldt D, Whiting J. Micra Transcatheter Pacing System Device Volume Characterization Comparison. November 2014. Medtronic data on file

Brief statement

See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan™ device, see the MRI SureScan™ technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.

For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.

Important Reminder: this information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.