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MicraTM

Transcatheter pacing system for bradyarrhythmia management

The Micra™ transcatheter pacing system (TPS) is the world’s smallest pacemaker,1 delivered percutaneously via a minimally invasive approach, directly into the right ventricle and does not require the use of leads.

Meet Micra™ AV now with AV Synchrony2, 11

The future is here

Allowing more of your patients to benefit from leadless pacing.


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 transvenous 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

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


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 pacing2
  • New, integrated circuitry capable of sustaining new AV synchrony functionality2
  • 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 block5,7


Same, streamlined procedure

> 99% implant success in  

Micra™ VR* clinical studies10, 12

 

Micra™ AV and Micra™ VR use the same implant
tools for deployment and delivery.10, 12

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)

Micra™ VR
procedural performance10, 12

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

  • > 99% implant success rate in Micra™ VR* clinical studies
  • 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


Micra™ videos

Learn about the Micra VR design journey
More information (see more) Less information (see less)

Micra AV transcatheter pacing system (TPS), the world smallest pacemaker
More information (see more) Less information (see less)

Micra™ clinical evidence

Educational resources on Medtronic Academy

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

Request more information

*

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

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.