Alert Indications, Safety, and Warnings

Micra 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
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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

Animation showing Micra is 93% smaller than regular pacemakers

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

12 years‡8

Accelerometer-based Mechanical Atrial Sensing

Yes

N/A

Accelerometer-based Rate Response

Yes

Yes

MRI SureScan™

1.5T & 3T

1.5T & 3T
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

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 3-way stopcock
Graphic showing parts of the Micra Introducer

CLINICAL EVIDENCE 

Micra AV Algorithm Performance11

The MARVEL 2 trial is a multicenter, pivotal IDE study in which the MARVEL 2 algorithm was downloaded into existing Micra VR devices in order to provide AV synchronous pacing.

  • 94.3% median AV synchrony at rest in complete AV block patients with normal sinus rhythm (n = 40)
  • Mean AV synchrony increased from 26.8% during VVI pacing to 89.2%
  • 95% of patients (38 of 40) with complete AV block and normal sinus rhythm had ≥ 70% AV synchrony
  • 8.8% improvement in stroke volume as measured by LVOT VTI (n = 39)
VIEW Micra AV Full 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

Micra videos 

Learn about the Micra VR design journey - (02:45)

See how Micra is implanted (03:33)

Watch how Micra VR allows 92-year-old Roy to stay busy and active - (01:41)

Watch how Micra VR allows singer Stephen to live without worry - (02:28)

Model Specifications

pdf Micra AV Transcatheter Pacing System (.pdf)

1.2MB

pdf Micra Delivery Catheter (.pdf)

659KB

pdf Micra VR Transcatheter Pacing System (.pdf)

600KB

pdf Micra Introducer Sheath (.pdf)

586KB

Medtronic 24-hour support

1-800-505-4636

Educational Resources on Medtronic Academy

Find additional feature information along with a variety of educational resources and tools.

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.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. 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

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

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.

12

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.