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Catalog excerpts

Micra™ - 1

THE FUTURE IS HERE Meet Micra™ AV Now offering two leadless pacing options Micra AV and Micra VR Transcatheter Pacing Syst

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Micra™ - 2

UNMATCHED LEADLESS PACING EXPERIENCE World’s smallest pacemaker2 – 93% smaller than conventional pacemakers3 n ,500+ patients studied in IDE & PAR trials4-6 2 – 63% fewer major complications than traditional pacemakers4 n ,000+ Micra VR* Medicare claims studied 5 – 66% reduction in risk of complications at 6 months relative to transvenous devices7 n irst and only FDA-approved leadless F pacemaker portfolio n AV SYNCHRONY REIMAGINED Accelerometer-based mechanical atrial sensing8 – Median AV synchrony at rest in complete AV block patients with normal sinus rhythm: 94.3% – Mean AV synchrony...

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Micra™ - 3

UNMATCHED LEADLESS PACING EXPERIENCE Together, we can provide new opportunities to redefine the patient experience and reduce complications associated with traditional pacing technology.11 Micra AV and Micra VR* Transcatheter Pacing Systems Redefined Patient Experience No chest scar ■ No bump ■ No visible or physical reminder of a pacemaker under the skin ■ Fewer post-implant activity restrictions ■ Eliminated Pocket-related Complications12 Infection ■ Hematoma ■ Erosion ■ Eliminated Lead-related Complications12 Fractures Insulation breaches ■ Venous thrombosis and obstruction ■ Tricuspid...

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Micra™ - 4

Micra AV provides AV synchrony,1 allowing more of your patients to benefit from leadless pacing. Now offering two leadless pacing options UNMATCHED LEADLESS PACING EXPERIENCE AVB + AF AVB Only* Other SND + AVB Pacing Capsule Technical Specifications Pacing Mode Electrode Spacing Battery Longevity Programmer Accelerometer-based Mechanical Atrial Sensing Accelerometer-based Rate Response CareLink 2090 Encore™ Programmer CareLink 2090 Encore Programmer Capture Management™ FlexFix Nitinol Tines CareLink™ Remote Monitoring AVB only patients who would benefit from leadless pacing per the...

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Micra™ - 5

Bipolar pacing Proximal Retrieval Feature FlexFix Nitinol Tines ■ Multidimensional redundancy: two tines have 15x the holding force necessary to hold the device in place17 Designed to minimize tissue trauma during deployment, repositioning, and retrieval18 Optimal electrode tissue interface allows for low and stable chronic thresholds19 Steroid-eluting electrode Separated from FlexFix tines to ensure optimal contact with

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Micra™ - 6

AV SYNCHRONY REIMAGINED The World’s Smallest Pacemaker2 Now with AV Synchrony1 ■ Micra AV’s accelerometer detects mechanical atrial activity and uses this information to deliver AV synchronous ventricular pacing1 Incorporates new, integrated circuitry capable of sustaining new AV synchrony functionality1 Delivers estimated average battery longevity of 8–13 years, dependent on the patient’s degree of AV block9,10 Atrial mechanical (AM) marker Marker that indicates the device detected the atrial mechanical contraction or A4. Ventricular end (VE) marker The end of the A1–A3 ventricular-event...

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Micra™ - 7

11 New Algorithms,1 Including: AV CONDUCTION MODE SWITCH1 Micra AV will mode switch to VVI 40 during periods of intact AV conduction to promote intrinsic rhythm in patients with episodic AV block. 1. Designed to limit amount of RV pacing and maximize device longevity by disabling atrial sensing during mode switch. 2. Aims to detect intact AV conduction by periodically dropping into VVI 40 (VVI + mode). 3. Switches back to VDD mode when device paces at 40 bpm. 4. AV conduction mode switch can be programmed to ON or OFF. RATE SMOOTHING1 Allows the device to preserve AV synchrony through short...

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Micra™ - 8

SAME, STREAMLINED PROCEDURE SUCCESS IN MICRA VR CLINICAL STUDIES4,5 Micra Integrated Delivery Catheter 105 cm long catheter system with a handle that controls deflection and deployment of the Micra pacing capsule14 Micra Delivery Catheter Micra Pacing Capsule Radiopaque Marker Band Radiopaque Marker Band Micra Introducer Delivery catheter provides visual feedback when adequate tip pressure has been achieved, and retracts during deployment.14 Linear, one-step deployment facilitates consistent capsule placement; no torque required.17

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Micra™ - 9

Tether Pin Device Deployment Button Curve Deflection Button Tether Lock Button Flush Port Smooth Vessel Navigation with the Micra Introducer ■ Lubricious hydrophilic coating 23 Fr inner diameter (27 Fr outer diameter) Silicone oil-coated dilator tip 56 cm (22 in) working length Extended Distal Taper Side Port with 3-way Stopcock Device Lifecycle Management Options ■ Micra is designed to offer options – Micra can be programmed Off at the end of service and can be differentiated from additional Micra devices, if subsequent devices are implanted The Micra design incorporates a proximal...

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Micra™ - 10

CLINICAL EVIDENCE Micra AV Algorithm Performance8 MARVEL 2 Trial (n = 75)* ■ 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. The target patient population included patients with an existing Micra VR implant who had AV block without persistent atrial arrhythmia. Number of enrolled patients that received the software download. The primary efficacy objective was to characterize the rate of AV synchrony at rest for 20 minutes in complete AV block patients with normal...

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Micra™ - 11

Micra VR Procedural Performance Data from Micra VR IDE, Post-approval Registry, and Coverage with Evidence Development 96% of patients experienced no major complications by 12-month follow-up15 – 0 dislodgements or systemic infections – Low (0.4%) revision rate Pacing thresholds remained low and stable through 12 months15 – Yielding an estimated battery longevity on average of 12.1 years 63% fewer major complications than traditional pacemakers*4 Micra VR IDE Micra VR Global Registry Reference Dataset Major Complication Rate (%) Primary prespecified safety, effectiveness, and long-term...

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Micra™ - 12

References 1 Medtronic Micra™ AV MC1AVR1 Reference Manual. January 2020. 2 Nippoldt D, Whiting J. Micra Transcatheter Pacing System Device Volume Characterization Comparison. November 2014. Medtronic data on file. 3 Williams E, Whiting J. Micra Transcatheter Pacing System Size Comparison. November 2014. Medtronic data on file. 4 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. 5 Reynolds...

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