MEET

MICRA
25.9mm

Yes,
this is actual size

Micra TM

Transcatheter Pacing System

Micra™ The world’s
Transcatheter Pacing System
smallest
cardiocapsule1
MINIATURIZED.
93% smaller than modern-day pacemakers7
■ Completely self contained within the heart, no leads required
■ New ultra low power circuit design delivers a 12-year longevity3,4

SOPHISTICATED.
Engineered for a minimally invasive approach
■ Atraumatic FlexFixTM nitinol tines provide secure capsule placement8,9
■ I ntegrated delivery system facilitates a streamlined implant procedure
via a percutaneous, femoral approach

New opportunities to Redefined Patient Experience

No chest scar

COMPLETE.
■

redefine the patient ■ No bump

experience and reduce ■ No visible or physical reminder

complications associated
with traditional pacing
technology2
of a pacemaker under the skin The only transcatheter pacing system to offer a complete feature set3,10,11
■ Fewer post-implant activity restrictions
■ 12-year battery longevity3,4
■  RI SureScan™ Technology, which allows the patient to be safely scanned using
M
Eliminated Pocket-Related
Complications5
either a 1.5 T or 3 T full body MRI3
■ Accelerometer based rate response
■ Infection ■ CareLink™ 2090 Programmer compatible; no accessories required
■ Hematoma
■ Capture Management™
■ Erosion

Eliminated Lead-Related
Complications5
■ Fractures
■ Insulation breaches
■ Venous thrombosis and obstruction

■ Tricuspid regurgitation

FlexFix
tines
Long-Term Lead and Pocket-Related
Complications with Traditional Systems Circuit
board Battery
■ Pocket-related complications 8% at 5 years
5

>99 %
63 % Lead-related complications 11% at 5 years5
■

Implant Fewer Major

Success3,6 Complications6
vs Transvenous
Pacemakers
MINIATURIZED. Primary pre-specified safety, effectiveness, and long-term safety
objectives were met3,4

SOPHISTICATED. § 96% of patients experienced no major complications by 12 months follow-up4

– 0 dislodgements or systemic infections

COMPLETE.
– Low (0.7%) revision rate
§ Pacing thresholds remained low and stable through 24 months – estimated battery longevity of 12.1 years
based on use conditions at 12 months.4

Lower rate of complications

Device life cycle management options 100% HR (Registry vs Ref): 0.37 (95% CI: 0.27-0.52)
CARDIOCAPSULE11 Micra IDE
Reference Dataset
P-value: <0.01
HR (Registry vs IDE): 0.71 (95% CI: 0.44-1.1)
Parameter Micra ■ M
 icra is designed to offer options Micra Global Registry
P-value: 0.160
10%
Pacing Mode VVIR – Micra can be programmed off at the end of service 80%
and can be differentiated from additional Micra
Mass 1.75 g

Major Complication Rate (%)

8%
devices, if subsequent devices are implanted
Volume 0.8 cc ■ The Micra design incorporates a proximal retrieval 60% 6%
Electrode feature to enable acute retrieval

63%
Spacing 18 mm – Successful retrieval demonstrated after 4%

Programmable 3-axis 28 months in chronic animal models12 40%

Accelerometer 2%

0%
20%
0 3 6 9 12 15 18 21 24 Fewer Major
Complications6
ANODE vs Transvenous
■ Bipolar pacing 0% Pacemakers*
0 3 6 9 12 15 18 21 24
*H
 istorical cohort
Number at Risk Months from Implant comprised of 2,667
patients from
IDE 726 684 671 658 639 432 251 106 42
6 trials of commercially
Global 1817 1008 846 630 458 222 144 64 28 available technology.
Ref 2667 2260 1965 1698 1526 1319 1212 1137 1002
PROXIMAL
RETRIEVAL
FEATURE

CATHODE FlexFix Nitinol Tines

■ Steroid eluting electrode
■ Separated from FlexFix
■  ultidimensional redundancy: two tines
M
tines to ensure optimal have 15 times the holding force necessary
contact with myocardium to hold the device in place9
■  esigned to minimize tissue trauma
D
during deployment, repositioning and retrieval8
■  ptimal electrode tissue interface allows
O
for low and stable chronic thresholds13
 STREAMLINED
>99% IMPLANT PROCEDURE
IMPLANT WITH INTEGRATED
SUCCESS3,6 DELIVERY SYSTEM
Tether Pin

Device Deployment Curve Deflection Tether Lock

Micra Delivery Catheter Button Button Button
■  05 cm long catheter system with a handle that controls
1
deflection and deployment of the Micra pacing capsule3

Flush Port

Micra Delivery Catheter Micra Cardiocapsule

SMOOTH VESSEL NAVIGATION

WITH THE MICRA INTRODUCER
Radiopaque ■ Lubricious Hydrophilic Coating
Marker Band
■ 23 Fr inner diameter (27 Fr outer diameter)
Radiopaque
Micra Marker Band ■ Silcone oil coated dilator tip
Introducer

Delivery catheter Linear one-step

provides visual feedback deployment facilitates
when adequate tip consistent capsule 56 cm (22 in) working length
pressure has been placement, no torque
achieved and retracts required.11
during deployment.11
Extended Distal Taper

Side Port with 3-way Stopcock

References
1
Nippoldt, Doug; Whiting, Jon. Micra Transcatheter Pacing System: Device Volume
Characterization Comparison. November 2014. Medtronic Data on File.
2
Ritter P, Duray GZ, Zhang S, et al. The rationale and design of the Micra
Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.
Europace. May 2015;17(5):807-813.
3
Reynolds DW, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing
System. N Engl J Med. February 11, 2016;374(6):533-541.
4
Duray GZ, Ritter P, El-Chami M, Narasimhan C, Omar R, Tolosana JM, Zhang S,
Soejima K, Steinwender C, Rapallini L, Cicic A. Long-term performance of a
transcatheter pacing system: 12-Month results from the Micra Transcatheter
Pacing Study. Heart Rhythm. 2017 May 1;14(5):702-9.
5
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.
6
El-Chami MF, et al. Leadless Pacemaker Implant in Patients with Pre-existing
Infections: Results from the Micra Post-approval Registry. Presented at: HRS 2018;
May 10, 2018; Boston, MA.
7
Williams, Eric; Whiting, Jon. Micra Transcatheter Pacing System Size Comparison.
November 2014. Medtronic Data on File.
8
Eggen, Mike. FlexFix Tine Design. April 2015. Medtronic Data on File.
9
Eggen M, Grubac V, Bonner M. Design and Evaluation of a Novel Fixation
Mechanism for a Transcatheter Pacemaker. IEEE Trans Biomed Eng. September
2015;62(9):2316-2323.
10
St. Jude Medical Nanostim™ Leadless Pacemaker, Nanostim Delivery System
Catheter Instructions for Use, January 2014.
11 
Medtronic Micra Implant Manual. April 2015.
Bonner MD, Neafus N, Byrd CL, et al. Extraction of the Micra transcatheter
12 

pacemakersystem. Heart Rhythm. May 2014;11(5):S342.

13 
Bonner M, Eggen M, Haddad T, Sheldon T, Williams E. Early Performance and Safety
of the Micra Transcatheter Pacemaker in Pigs. Pacing Clin Electrophysiol. November
2015;38(11):1248-1259.

*CE Mark 14 April 2015 - FDA 6 April 2016.

´

Brief Statement
See the device manual for detailed information regarding the implant procedure,
indications, contraindications, warnings, precautions, and potential adverse events
For further information, contact your local Medtronic representative and/or consult
the Medtronic website at www.medtronic.com.
.

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

cardiocapsule
miniaturized | sophisticated | complete

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