THE FUTURE IS HERE

UNMATCHED FEATURE SUITE

• Exclusive algorithms to manage atrial fibrillation (AF) in pacemaker patients
• Reduce unnecessary RV pacing with MVP™ feature
• Improved longevity - updated hardware architecture optimizes circuitry (to reduce current drain)
• Unmatched MRI access - 1.5T and 3T full body scanning

REIMAGINED CONNECTIVITY

BlueSync™ technology that enables tablet-based programming and app-based remote monitoring

STREAMLINED WORKFLOWS

• Manage alerts of clinically relevant events with additional CareAlert™ notifications
• MyCareLink Heart™ mobile app is designed to increase clinic efficiencies through patient compliance

Atrial Fibrillation (AF) Is Prevalent and Clinically Challenging

1 in 3 CIED patients will develop new onset AF within the first 2.5 years of implant¹

Increases the risk of heart failure greater than 3-FOLD²

5-FOLD increase in ischemic stroke risk for AF patients³

Exclusive Algorithms to Manage AF in Patients

DETECT

Highest published AF episode detection accuracy (PPV)^*4-7

95-96% AF episode detection accuracy (PPV)^5-7

REDUCE

Exclusive algorithms demonstrated to reduce the risk and duration of AF

36% relative reduction in AT/AF episodes ≥ 7 days with Reactive ATP™ Algorithm⁸

*A controlled, head-to-head study evaluating the comparative performance of device algorithms has not been done. AF detection accuracy rates determined from independent clinical trials are presented for reference. Detection accuracy is compared using PPV, which is the percentage of all AT/AF episodes detected by the individual device detection algorithm that were adjudicated as true AT/AF.

Exclusive Algorithms to Manage AF in Patients

Reduce duration of AF⁸ with Reactive ATP

Reactive ATP provides an opportunity to terminate an ongoing AF episode by delivering ATP during those times when the rhythm has organized and/or slowed.

Analysis design

An analysis design of 8,032 patients in the Medtronic CareLink™ database assessed the impact of Reactive ATP across pacemakers, ICDs, and CRT devices.⁸

RESULTS

Reactive ATP is associated with a reduction in the duration of AT/AF⁸:

• ≥ 1 day by 19%
• ≥ 7 days by 36%
• ≥ 30 days by 44%

36% reduced risk of persistent AF^*8

*Compared to matched control group; matched components included age, sex, baseline AF and percent VP, pacing mode, and device type.

Simple programming nominals updated to MINERVA⁹ settings.

Reduce Unnecessary RV Pacing¹⁰ with MVP Feature

Now updated with the option to control maximum AV interval

• RV pacing is associated with an increased risk of HF hospitalization.¹¹
• RV pacing is associated with a 1% increase in risk of AF for each 1% increase in cumulative RV pacing.¹¹
• MVP algorithm reduces unnecessary RV pacing by 99%.¹⁰

MVP Logic Diagram:

AAI(R) [logic flow] Persistent loss of AV conduction or AV internal exceeds programmed max interval [logic flow] DDD(R)

Improved Longevity

Updated hardware architecture optimizes circuitry to reduce current drain and improve longevity.¹²

Longevity Comparison:

• Azure XT SR MRI: 15.8 YEARS (+24%) compared to Advisa SR MRITM: 12.7 YEARS
• Azure XT DR MRI: 13.7 YEARS (+27%) compared to Advisa DR MRITM: 10.8 YEARS

*Projected service life estimates assume device configuration at VVI 50%, 2.5V, 500 Ohm lead impedances, Pre-storage EGM off. Projected service life estimates are based on accelerated battery discharge data and device modeling. The values calculated based on this information should not be interpreted as precise numbers. Individual patient results may vary based on their specific programming and experience.

*Projected service life estimates assume device configuration at MVP 50% AP, 5% VP, 2.5V in both chambers, 500 Ohm lead impedances, Pre-storage EGM off. Projected service life estimates are based on accelerated battery discharge data and device modeling. The values calculated based on this information should not be interpreted as precise numbers. Individual patient results may vary based on their specific programming and experience.

UNMATCHED MRI ACCESS

With Azure MRI, Patients Have Access to 1.5T and 3T Full Body Scanning.¹³

Built to be scanned

• SureScan™ devices were specifically engineered for the MRI environment, with enhancements that ensure patient safety during an MRI scan.^*
• Scanning conditions are simple: no MRI exclusion zone, no patient height restriction, no MRI duration restriction.¹³

*For a complete list of approved device and lead combinations, please visit mrisurescan.com.

[Human Body MRI Illustration]

REIMAGINED CONNECTIVITY

BlueSync Technology

Azure with BlueSync technology enables secure, wireless communication.

System Components:

• Tablet-based CareLink SmartSync™ device manager
• Azure™ pacemaker engineered with BlueSync technology
• MyCareLink Heart mobile app or MyCareLink Relay™ Home Communicator
• CareLink network
• Supported by the Get Connected service

Security Measures¹⁴

BlueSync Technology Security

BlueSync technology security was designed to protect the device, patient data, and connectivity.

• Device Protection: Pacemaker doesn't accept programming from unauthorized sources. Device not connected to internet. Devices do not have an IP address, unlike other connected consumer products.
• Data Privacy: End-to-end encryption. Data are encrypted in the pacemaker using NIST* government standard for security before being transmitted to the CareLink network.

*NIST: National Institute of Standards and Technology.

Key Components of BlueSync Technology

• Bluetooth® Low Energy: enabled to securely¹⁴ communicate with Bluetooth Low Energy smartphones or tablets. [Bluetooth Logo]
• Encryption Technology: Data are encrypted in the pacemaker using NIST* standard encryption.
• High-density Integrated Circuit: reduces current drain for increased longevity.

Please go to medtronic.com/security for up-to-date security information.

MyCareLink Heart Mobile App

Patients can now use their smartphone to automatically transfer device data via the MyCareLink Heart mobile app, even outside the home (where cellular or Wi-Fi connectivity is available).^*

• My Heart Device: Displays battery longevity, implant date, heart device name, serial number, and patient's clinic information. [Heart Device Icon]
• My Transmissions: Has information about transmissions sent from a patient's heart device to their clinic.
• Physical Activity: The app uses data from patient's heart device to create daily, weekly, and monthly views of physical activity.
• Education: Provides information about living with a heart device.
• Connectivity Status: Green check mark confirms Bluetooth® is ON and the app was connected recently.

Patients are required to keep their smartphone/ tablet up to date to use the app.

Alternative Monitoring Option

MyCareLink Relay Home Communicator

MyCareLink Relay offers a monitoring alternative to patients who prefer not to use a smartphone.

• No manual pairing required
• Requires little to no user interaction

Available on iOS and Android™.

*Please visit MCLHeart.com for a list of compatible smartphones and tablets.

MyCareLink Relay must be plugged in and patients must be within communication range for successful transmissions. Requires Wi-Fi or cellular connection.

STREAMLINED WORKFLOWS

Timely Alerts of Clinically Relevant Events^14,15

Time to a clinical decision was ~7x faster with the use of Medtronic CareAlert notifications compared to standard office follow-up.¹⁶

CareAlert notifications can be programmed and viewed only by the clinician:

• AT/AF Burden Notification
• Lead Impedance
• Low Battery Voltage @ RRT
• VT Episodes
• Fast V. Rate during AT/AF
• Capture Management™
• % V. Pacing

Wireless alerts can now be transmitted via Bluetooth using the MyCareLink Heart mobile app, providing patient monitoring -- even outside the home.

MyCareLink Heart Mobile App Benefits

• Patient Engagement Promotes Patient Satisfaction¹⁷ [Satisfaction Icon]
• Integrate remote monitoring into your patient's daily life using a patient-owned smartphone and eliminate the need for a bedside monitor.
• Provide patient peace of mind with the MyCareLink Heart app, which allows patients to view select data such as transmission status.
• Activated patients are significantly more likely to engage in healthy behaviors.¹⁸

• Patient Compliance Results in Increased Clinic Efficiencies¹⁹ [Efficiency Icon]
• Patient monitoring -- even outside the home -- helps deliver quality of care in line with HRS guidelines.
• Reduce clinic time spent on follow-up activities.
• Push notifications help patients stay connected, transmit on time, and verify that transmissions were sent.

• Upgradeability Sets the Foundation for Future Technologies [Future Tech Icon]
• Similar to consumer apps, as technology advances, so will MyCareLink Heart -- throughout the life of the pacemaker.

References

1. Boriani G, Glotzer TV, Ziegler PD, et al. Detection of new atrial fibrillation in patients with cardiac implanted electronic devices and factors associated with transition to higher device-detected atrial fibrillation burden. Heart Rhythm. March 2018;15(3):376-383.
2. Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. October 1, 2002;113(5):359-364.
3. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. August 1991;22(8):983-988.
4. Sprenger M. Comparison of Manufacturer's AT/AF Detection Accuracy across Clinical Studies. Medtronic data on file. January 2015.
5. Pürerfellner H, Gillis AM, Holbrook R, Hettrick DA. Accuracy of atrial tachyarrhythmia detection in implantable devices with arrhythmia therapies. Pacing Clin Electrophysiol. July 2004;27(7):983-992.
6. Ziegler PD, et al. Accuracy of Atrial Fibrillation Detection in Implantable Pacemakers. Presented at HRS 2013 (PO02-08).
7. Medtronic data on file. QADoc DSN026170, Version 2.0, "AT/AF Duration Performance Comparison."
8. Crossley GH, Padeletti L, Zweibel S, Hudnall JH, Zhang Y, Boriani G. Reactive atrial-based antitachycardia pacing therapy reduces atrial tachyarrhythmias. Pacing Clin Electrophysiol. July 2019;42(7):970-979.
9. Padeletti L, Pürerfellner H, Mont L, et al. New-generation atrial antitachycardia pacing (Reactive ATP) is associated with reduced risk of persistent or permanent atrial fibrillation in patients with bradycardia: Results from the MINERVA randomized multicenter international trial. Heart Rhythm. August 2015;12(8):1717-1725.
10. Chen S, Chen K, Tao Q, et al. Reduction of unnecessary right ventricular pacing by managed ventricular pacing and search AV+ algorithms in pacemaker patients: 12-month follow-up results of a randomized study. Europace. November 2014;16(11):1595-1602.
11. Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. June 17, 2003;107(23):2932-2937.
12. Orenga M. Azure™ longevity increase compared to Advisa™. September 2017. Medtronic data on file.
13. M964377A001 Azure™ MRI SureScan™/Astra™ MRI SureScan™ pacing systems MRI Technical Manual.
14. Medtronic Azure™ XT DR MRI SureScan™ Device Manual. M964338A001B. 2016-10-22.
15. Howard K. Alert Notification Timing. September 2017. Medtronic data on file.
16. Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH; CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol. March 8, 2011;57(10):1181-1189.
17. Varma N. Remote monitoring of patients with CIEDs following the updated recommendations--Easing or adding to postimplant responsibilities? Cont Cardiol Educ. December 2016;2(4):198-204.
18. Fowles JB, Terry P, Xi M, Hibbard J, Bloom CT, Harvey L. Measuring self-management of patients' and employees' health: Further validation of the Patient Activation Measure (PAM) based on its relation to employee characteristics. Patient Educ Couns. 2009;77(1):116-122.
19. Cronin EM, Ching EA, Varma N, Martin DO, Wilkoff BL, Lindsay BD. Remote monitoring of cardiovascular devices: a time and activity analysis. Heart Rhythm. December 2012;9(12):1947-1951.

Brief Statements

Azure™ MRI SR and DR IPG

Indications

The Azure DR MRIT™ and Azure SR MRIT™ SureScan™ systems are indicated for the rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. Accepted patient conditions warranting chronic cardiac pacing include symptomatic paroxysmal or permanent second- or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, or bradycardiatachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias. The Azure DR MRI devices are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output, VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm, or vasovagal syndromes or hypersensitive carotid sinus syndromes. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.

MRI Conditions for Use

Medtronic SureScan pacing systems are MR conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. Pacemaker SureScan system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan pacing system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.

Contraindications

The Azure DR MRI and Azure SR MRI SureScan systems are contraindicated for concomitant implantation with another bradycardia device or with an implantable cardioverter defibrillator. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. ATP therapy is contraindicated in patients with an accessory antegrade pathway.

Warnings and Precautions

Changes in a patient's disease and/or medications may alter the efficacy of the device's programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device should not change the application of established anticoagulation protocols. Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the device must be operating within the projected service life; and the system must be implanted in the left or right pectoral region.

Potential Adverse Events or Potential Complications

Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.

See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications. For further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.

Medtronic Model 24970A CareLink SmartSync™ Device Manager Base and Associated Apps

Indications

The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

Contraindications

The base is not intended for use as an external pulse generator (EPG) outside of the implant procedure. In addition, the patient's age and medical condition may dictate the lead analyses appropriate for the patient.

See the CareLink SmartSync 24970A and Technical Manual and 24967 Patient Connector Technical Manual before using the CareLink SmartSync device manager for detailed information regarding the procedure, indications, or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.

Medtronic Model 24967 Patient Connector and Associated Apps

Indications

The patient connector is intended to be used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronic devices. The patient connector uses Bluetooth® technology to transmit that data to a Medtronic app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment.

Precautions

Security - Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.

See the CareLink SmartSync 24967 Patient Connector Technical Manual before using the CareLink SmartSync device manager for detailed information regarding the procedure, indications, or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.

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

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.