THE FUTURE IS HERE

Medtronic presents the Cobalt™ ICDs and CRT-Ds, designed to offer advanced cardiac rhythm management solutions.

UNMATCHED FEATURE SUITE

• Extended Longevity and Higher Output: Maintains exclusive PhysioCurve™ size and shape.
• Reduced Shocks: Features exclusive technology to reduce shocks.
• Optimized CRT: Incorporates exclusive algorithms to optimize CRT.
• AF Management: Includes exclusive algorithms to manage atrial fibrillation (AF).

Extended Longevity Projections (based on CareLink™ patient data):

• Claria MRI™ Quad and Amplia MRI™ Quad CRT-Ds: 8.3 Years
• Cobalt HF Quad CRT-Ds: 10.1 Years
• Evera MRI™ XT and Evera MRI™ S ICDs: 10.5 Years
• Cobalt Dual Chamber ICDs: 11.9 Years
• Visia AF MRI™ Single Chamber ICDs: 12.0 Years
• Cobalt Single Chamber ICDs: 13.6 Years

Note: Longevity projections are estimates and individual patient results may vary.

Option for 40 J Energy Delivery on All Shocks:

• Maximum Programmed Energy: 40 J
• Maximum Delivered Energy: 40 J
• Maximum Stored Energy: 47 J

PhysioCurve™ Design: Showed a 30% reduction in overall skin pressure compared to noncontoured devices. Features a tapered design for reduced skin pressure and patient comfort, a smaller footprint for a smaller incision, and is designed with lead wrap in mind to minimize stress on the lead.

SmartShock™ 2.0 Technology: Offers the lowest inappropriate shock rate, utilizing six exclusive algorithms to discriminate true lethal arrhythmias from other arrhythmic and nonarrhythmic events.

• Inappropriate shock rate in dual and triple chamber patients at one year: 1.5%
• Inappropriate shock rate in single chamber patients at one year: 2.5%

Exclusive Algorithms to Optimize CRT Delivery:

AdaptivCRT™ Algorithm: Adapts to patients' changing needs by optimizing CRT pacing minute-to-minute.

• Improvement in CRT Response: 12% improvement in CRT patient response with AdaptivCRT.
• Relative Reduction in Mortality: 29% relative reduction in mortality associated with AdaptivCRT.
• Reduction in Hospitalizations: 59% reduction in a patient's odds of 30-day HF readmission with AdaptivCRT.

Exclusive Algorithms to Manage AF:

DETECT:

• Single Chamber: TruAF™ Detection Algorithm detects AF in single chamber ICD patients using a traditional lead.
• Dual Chamber and CRT-D: Highest published AF episode detection accuracy (PPV).

AF Episode Detection Accuracy (PPV):

• Medtronic: 95-96%
• St. Jude Medical: 83% (Episodes > 6 min), 48% (A Rate > 190 bpm)
• Boston Scientific: 62% (A Rate > 190 bpm, 4 atrial cycles)

REDUCE:

• CRT-D: 46% reduction in AF risk with AdaptivCRT Algorithm.
• Dual Chamber and CRT-D: 36% relative reduction in AT/AF episodes ≥ 7 days with Reactive ATP™ Algorithm.

REIMAGINED CONNECTIVITY

BlueSync™ Technology: Enables secure, wireless communication for Cobalt ICDs and CRT-Ds.

• Components: Tablet-based CareLink SmartSync™ device manager, Cobalt ICDs and CRT-Ds, MyCareLink Heart™ mobile app or MyCareLink Relay™ Home Communicator, CareLink network, and Get Connected service.

Security Measures:

• Device Protection: BlueSync devices do not accept programming from unauthorized sources and are not connected to the internet.
• Data Privacy: End-to-end encryption using NIST government standard for security before transmission to the CareLink network.

Increase Patient Adherence, Save Lives: Remote monitoring helps patients stay adherent, leading to improved outcomes.

• 50% potential increase in survival rate.
• 35% potential reduction in ER visits.
• 18% potential reduction in length of hospital stay.

MyCareLink Heart: Results in 94.6% patient adherence to transmission schedule compared to 77% for bedside monitors.

Alternative Monitoring Option: MyCareLink Relay Home Communicator: A Bluetooth home communicator for easy and reliable monitoring, requiring no manual pairing and little to no user interaction.

STREAMLINED WORKFLOWS

Additional CareAlerts:

• Tachyarrhythmia Status: Monitored VT, Weekly ATP delivered, Daily VT/VF episodes.
• Bradyarrhythmia Status: Right ventricular pacing > 40%, High capture thresholds.
• Heart Failure Status: Ventricular pacing < 90%, OptiVol™ 2.0 Fluid Status Monitoring (CRT-D).

Built for MRI:

Cobalt MRI devices and leads are compatible with 1.5T and 3T full body MRI scans under specified conditions. Scanning is simple with no MRI exclusion zone, patient height restriction, or MRI duration restriction. BiV pacing is available in MRI SureScan mode.

References

1. Medtronic Complia MRI™ CRT-D, Amplia MRI™ CRT-D, and Claria MRI™ CRT-D Mean Projected Service Life based on U.S. CareLink™ transmission data as of January 2019; UC201802366 EN.

2. Medtronic Cobalt™ HF Quad CRT-D MRI SureScan™ Model DTPB2QQ device manual.

3. Medtronic Evera MRI™ XT DR SureScan™ and Evera MRI™ S DR SureScan™ Mean Projected Service Life based on U.S. CareLink™ transmission data as of January 2019; UC201802366 EN.

4. Medtronic Cobalt™ DR MRI SureScan™ Model DDPB3D4 device manual.

5. Medtronic Visia AF™ VR SureScan™ Mean Projected Service Life based on U.S. CareLink™ transmission data as of January 2019; UC201802366 EN.

6. Medtronic Cobalt™ VR ICD MRI SureScan™ Model DVPB3D4 device manual.

7. Flo D, et al. IS4/DF4 Device Shape Analysis. January 2013. Medtronic data on file.

8. Lulic T. March 26, 2013. Medtronic data on file.

9. Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm. May 2015;12(5):926-936.

10. Volosin KJ, Exner DV, Wathen MS, Sherfesee L, Scinicariello AP, Gillberg JM. Combining shock reduction strategies to enhance ICD therapy: a role for computer modeling. J Cardiovasc Electrophysiol. March 2011;22(3):280-289.

11. Birnie D, Lemke B, Aonuma K, et al. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. September 2013;10(9):1368-1374.

12. Singh JP, Cha YM, Lunati M, et al. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. April 2020;31(4):825-833.

13. Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.

14. Sprenger M. Comparison of Manufacturer's AT/AF Detection Accuracy across Clinical Studies. January 2015. Medtronic data on file. QADoc DSN026170, Version 2.0, "AT/AF Duration Performance Comparison."

15. Pürerfellner H, Gillis AM, Holbrook, Hettrick DA. Accuracy of atrial tachyarrhythmia detection in implantable devices with arrhythmia therapies. Pacing Clin Electrophysiol. July 2004;27(7):983-992.

16. Ziegler PD, et al. Accuracy of Atrial Fibrillation Detection in Implantable Pacemakers. Presented at HRS 2013 (PO02-08); Denver, CO.

17. Medtronic data on file. QADoc DSN026170, Version 2.0, "AT/AF Duration Performance Comparison."

18. Kauffman ES, Israel CW, Nair GM, et al. Positive predictive value of device-detected atrial high-rate episodes at different rates and durations: an analysis from ASSERT. Heart Rhythm. August 2012;9(8):1241-1246.

19. Nowak B, McMeekin J, Knops M, et al. Validation of dual-chamber pacemaker diagnostic data using dual-channel stored electrograms. Pacing Clin Electrophysiol. July 2005;28(7):620-629.

20. Birnie D, Hudnall H, Lemke B, et al. Continuous optimization of cardiac resynchronization therapy reduces atrial fibrillation in heart failure patients: Results of the Adaptive Cardiac Resynchronization Therapy Trial. Heart Rhythm. December 2017;14(12):1820-1825.

21. 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.

22. Saxon LA, Hayes DL, Gilliam FR, et al. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation. December 7, 2010;122(23):2359-2367.

23. Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S. Relationship between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients. J Am Coll Cardiol. June 23, 2015;65(24):2601-2610.

24. Akar JG, Bao H, Jones PW, et al. Use of Remote Monitoring is Associated with Lower Risk of Adverse Outcomes Among Patients with Implanted Cardiac Defibrillators. Circ Arrhythm Electrophysiol. October 2015;8(5):1173-1180.

25. 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.

26. Varma N. Rationale and design of a prospective study of the efficacy of a remote monitoring system used in implantable cardioverter defibrillator follow-up: the Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) study. Am Heart J. December 2007:154(6):1029-1034.

27. 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.

28. Tarakji KG, Zaidi AM, Zweibel SL, et al. Performance of First in the World Pacemaker to Use Smart Device App for Remote Monitoring. Late-breaking clinical trial presented online at HRS 2020.

Brief Statements

Cobalt™/Crome™ MRI SureScan™ ICD and CRT-D Systems Indications:

The Cobalt and Crome HF CRT-D MRI SureScan systems are indicated for patients at risk of developing atrial and/or life-threatening ventricular arrhythmias, and who have heart failure with ventricular arrhythmias. Heart failure patients must meet specific criteria related to NYHA Functional Class, LVEF, and QRS duration, or AV block and expected high ventricular pacing.

The Cobalt and Crome VR and DR ICD MRI SureScan systems are indicated for the automated treatment of patients at risk of developing atrial and/or life-threatening ventricular arrhythmias through antitachycardia pacing, cardioversion, and defibrillation therapies.

MRI Conditions for Use:

Medtronic SureScan ICD and CRT-D systems are MR Conditional, allowing MRI scans under specified conditions using 1.5T or 3T MRI systems. The SureScan feature allows the device to continue providing pacing during the scan. A complete SureScan defibrillation system (SureScan device with appropriate SureScan lead(s)) is required. Visit http://www.mrisurescan.com/ for system verification.

Contraindications:

Contraindications include implantation with a unipolar pacemaker, incessant VT or VF, primary disorder of chronic atrial tachyarrhythmia without concomitant VT or VF, and tachyarrhythmias with transient or reversible causes (e.g., acute myocardial infarction, drug intoxication, electrolyte imbalance).

Warnings and Precautions:

Changes in patient condition or medications may affect device efficacy. Patients should avoid sources of magnetic and electromagnetic radiation. Transthoracic defibrillation paddles should not be placed directly over the device. Patients and systems must meet specific MRI screening requirements, including lead integrity and device service life.

Potential Adverse Events:

Potential adverse events include allergic reactions, arrhythmias, cardiac arrest, device migration, discomfort, infection, lead dislodgement, oversensing, syncope, tissue damage, and wound complications.

Potential MRI Complications:

Potential MRI complications include lead electrode heating, tissue damage, spontaneous tachyarrhythmia, device heating, lead stimulation, hemodynamic collapse, device/lead damage, and movement or vibration of the device/leads.

Refer to device manuals and the MRI SureScan Technical Manual for detailed information. Contact Medtronic at 1-800-328-2518 or visit medtronic.com or mrisurescan.com.

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

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

The base is part of the CareLink SmartSync Device Manager system, used by clinicians to analyze cardiac lead performance during device implant or troubleshooting. It displays, measures, and records live cardiac waveforms. Intended for healthcare professionals only.

Contraindications: Not intended for use as an external pulse generator outside of implant procedures. Patient age and condition may dictate lead analyses.

Refer to the CareLink SmartSync 24970A and Technical Manual and 24967 Patient Connector Technical Manual. Contact Medtronic at 1-800-328-2518 or visit medtronic.com.

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

Medtronic Model 24967 Patient Connector and Associated Apps Indications:

The patient connector is used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronic devices via Bluetooth® technology. Intended for healthcare personnel in a clinical or hospital environment.

Precautions: Maintain physical security of the patient connector. Bluetooth communication is encrypted. Medtronic inductive telemetry uses short-range communication. Failure of the patient connector poses no risk of patient harm.

Refer to the 24967 Patient Connector Technical Manual. Contact Medtronic at 1-800-328-2518 or visit medtronic.com.

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