Alert Indications, Safety, and Warnings

Micra™ AV and Micra™ VR Pacemakers Transcatheter Pacing Systems

The miniaturized Micra AV and Micra VR* transcatheter pacing systems (TPS) are the world's smallest pacemakers1 for bradyarrhythmia management, delivered percutaneously via a minimally invasive approach without the use of leads.

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Alert Indications, Safety, and Warnings

Overview

The Future Is Here

Meet Micra AV

Now with AV synchrony,2 allowing more of your patients to benefit from leadless pacing.

Product Information
See How
Learn More
View Results

UNMATCHED LEADLESS PACING EXPERIENCE 

Redefined Patient Experience

  • No chest scar or bump
  • Fewer post-implant activity restrictions

Eliminated Pocket-related Complications3

  • Infection
  • Hematoma
  • Erosion

Eliminated Lead-related Complications3

  • Fractures
  • Insulation breaches
  • Venous thrombosis and obstruction
  • Tricuspid regurgitation

93% Smaller than regular pacemakers4

Now Offering Two Leadless Pacing Options

Parameter

Micra AV5

Micra VR6

Pacing Mode

VVI, VVIR, VOO, OVO, VDD, VDI, ODO, OFF

VVI, VVIR, VOO, OVO, OFF

Mass

1.75 g

1.75 g

Volume

0.8 cc

0.8 cc

Electrode Spacing

18 mm

18 mm

Battery Longevity

8–13 years†5,7

13.7 years‡8

Accelerometer-based Mechanical Atrial Sensing

Yes

N/A

Accelerometer-based Rate Response

Yes

Yes

MRI SureScan™

1.5T & 3T

1.5T & 3T

CareLink™ Remote Monitoring

Yes

Yes
View device details

AV Synchrony REIMAGINED 

Micra AV Provides AV Synchrony

Allowing more of your patients to benefit from leadless pacing.2
  • Accelerometer detects mechanical atrial activity and uses this information to deliver AV synchronous ventricular pacing.2
  • New, integrated circuitry capable of sustaining new AV synchrony functionality.2
  • 11 new algorithms,2 including:
    • AV Conduction Mode Switch
    • Rate Smoothing
    • Activity Mode Switch
  • Delivers an estimated average battery longevity of 8–13 years, dependent on patient’s degree of AV block.5,7
Learn about AV synchrony

SAME STREAMLINED PROCEDURE 

> 99% IMPLANT SUCCESS

Micra AV and Micra VR use
the same implant tools for
deployment and delivery.9,10

Micra Integrated Delivery Catheter


105 cm long catheter system with a handle that controls deflection and deployment of the Micra pacing capsule.6
 
  1. Device deployment button
  2. Curve deflection button
  3. Tether lock button 
  4. Tether pin 
  5. Flush port
Graphic showing parts of the Micra delivery catheter with numbered callouts

Smooth Vessel Navigation with the Micra Introducer

  • Lubricious hydrophilic coating
  • 23 Fr inner diameter (27 Fr outer diameter)
  • Silicone oil-coated dilator tip
  1. Extended distal taper
  2. 56 cm (22 in) working length
  3. Side port with three-way stopcock
Graphic showing parts of the Micra introducer with numbered callouts

CLINICAL EVIDENCE 

AccelAV study results11

The first prospective multicenter study concluded that Micra™ AV is an effective therapy for patients with AV block who would otherwise require a dual-chamber transvenous pacemaker.

View clinical data

Micra VR procedural performance10

Real-world experience reinforces safety and long-term performance of Micra VR.

  • > 99% implant success rate
  • Low major complication rate through 12 months (2.7%)
    • Low dislodgement rate (0.06%)
    • Low procedure-related infection rate (0.17%)
  • 63% fewer major complications than traditional pacemakers
VIEW Micra VR Full data

The largest claims-based evaluation of leadless pacemakers to date12

The Micra Coverage with Evidence Development (CED) Study compares Micra leadless-VVI pacemakers to transvenous-VVI pacemakers and provides insights into real-world comparative effectiveness of leadless pacemakers.

  • Significant 38% reduction in the rate of reintervention for patients receiving Micra VR versus TV-VVI
  • Significant 31% reduction in chronic complication rate at two years with Micra VR versus TV-VVI
  • No significant difference in adjusted two-year all-cause mortality between Micra VR and TV-VVI patients
View MICRA full CED data

Micra videos 

Micra VR Design Journey Video - (02:45)

See how Micra is implanted - (03:33)

Micra VR 92-year-old Patient Video - (01:41)

How Micra VR allows singer Stephen to live his life without worry - (02:28)

Model Specifications

pdf Micra AV Transcatheter Pacing System (.pdf)

1.2MB

pdf Micra Delivery Catheter (.pdf)

163KB

pdf Micra VR Transcatheter Pacing System (.pdf)

601KB

pdf Micra Introducer Sheath (.pdf)

85KB

Find a trained Micra physician.

Enter your ZIP code below to find a physician near you who is trained in Micra leadless pacing therapy. 

Medtronic 24-hour support

1-800-505-4636

Educational Resources on Medtronic Academy

Access interactive courses, videos, and educational resources to extend your learning on Micra.

Visit Medtronic Academy
*

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.13

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. January 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. January 2020.

6

Medtronic Micra™ MC1VR01 Clinician Manual. October 2016.

7

Pender J, Whiting J. Micra AV Battery Longevity. January 2020. Medtronic data on file.

8

Stromberg K. Micra VR CareLink Pacemaker Projected Battery Longevity Analysis. June 2022. Medtronic data on file.

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

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. September 6, 2022:S1547-5271(22)02380-3.

12

El-Chami MF, Bockstedt L, Longacre C, et al. Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. Eur Heart J. March 21, 2022; 43(12):1207-1215.

13

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.