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Viva XT CRT-D

IS1/DF4 DTBA2D4

IS1/DF-1 DTBA2D1

AdaptivCRT Algorithm

Ensure CRT Suite with CardioSync® In-Office AV/VV Delay Optimisation

SmartShock® Technology 2.0

Atrial Therapies

OptiVol® 2.0 Fluid Status Monitoring

PhysioCurve Design

EuropeMedtronic International Trading SàrlRoute du Molliau 31Case postaleCH-1131 TolochenazTel: +41 (0)21 802 70 00Fax: +41 (0)21 802 79 00

United Kingdom/IrelandMedtronic LimitedBuilding 9Croxley Green Business ParkHatters LaneWatfordHerts WD18 8WWwww.medtronic.co.uk Tel: +44 (0)1923 212213Fax: +44 (0)1923 241004

www.medtronic.eu

Every Patient Optimised. Every Minute.

Brief StatementSee the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.

EuropeMedtronic International Trading SàrlRoute du Molliau 31Case postaleCH-1131 TolochenazTel: +41 (0)21 802 70 00Fax: +41 (0)21 802 79 00

United Kingdom/IrelandMedtronic LimitedBuilding 9Croxley Green Business ParkHatters LaneWatfordHerts WD18 8WWwww.medtronic.co.uk Tel: +44 (0)1923 212213Fax: +44 (0)1923 241004

www.medtronic.eu

Brief StatementSee the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.

Viva® XT CRT-Dwith AdaptivCRT® Algorithm

Every Patient Optimised. Every Minute.

20%

15%

10%

5%

0%

25%

30%

35%

Perc

enta

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f Non

resp

onde

r Pat

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s w

ith T

hese

Fin

ding

s

< 90%Biventricular

Pacing

SuboptimalAV Timing

Arrhythmia Anemia SuboptimalLV LeadPosition

SuboptimalMedicalTherapy

PersistentMechanical

Dyssynchrony

UnderlyingNarrow

QRS

ComplianceIssues

Primary RVDysfunction

40%

45%

50%

There Are Many Drivers for CRT Non-ResponsePotential Reasons for Suboptimal CRT Response7

Viva® XT CRT-D

Up to one-third of patients do not experience the full benefit of CRT1-6

40%

30%

20%

10%

0%

50%

60%

70%

% Im

prov

ed

Clin

ical

Com

posi

te S

core

67%

52%58%

69% 67%

PROSPECT4MIRACLE1 MIRACLE ICD2

MIRACLE II ICD3

InSync IIIMarquis™,*,5

67%

FREEDOM6

80%

90%

100%

Medtronic takes a comprehensive approach, delivering solutions to optimise CRT response and manage heart

failure patients at every stage of care.1-5, 8-11

Optimise Therapy Benefits. At Every Stage of Care.

Every Patient Optimised. Every Minute.

CRT has greatly benefited heart failure patients1-3

• Decreased mortality • Improved quality of life • Reduced hospitalisation rates

Every Patient Optimised. Every Minute.

*AV optimised only

Viva XT CRT-D

AdaptivCRT®

Achieved with AdaptivCRT compared to Historical CRT Trials14

A 12% Absolute Higher CRT Response Rate

* A Propensity Score Analysis was used to compare AdaptivCRT trial results to historical CRT trials using Packer Clinical Composite Score. This type of analysis is used to make a fair comparison between different groups of patients.

Historical trial cohort included: MIRACLE, MIRACLE ICD, Prospect, and InSync III Marquis™,**.

0%

5%

10%

15%

% R

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Impr

oved

In A

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CRT

Tria

l

12%MVP® Mode –

Algorithm to reduce unnecessary RV

pacing15

Dual Chamber Pacing –

Restore AV synchrony

Rate Response – Re-establish chronotropic competence

CRT – Resynchronize

both ventricles1

A New Standard in CRT

AdaptivCRT Algorithm

Every Patient Optimised. Every Minute.

A New Standard in CRT12-14

• Dynamic Physiologic CRT, which promotes intrinsic RV conduction12

• Reduces RV pacing and increases longevity for patients with normal AV conduction12

Over 50 Yearso f Pa c i n g L e a d e r s h i p

** AV optimised only

[95% CI: 2.7% to 19.2%]

Unique minute-to-minute optimisation of CRT pacing method and AV/VV delays12

Normal AV Conduction

Adaptive LV pacing

Prolonged AV Conduction

Adaptive BiV pacing

Every Minute.

Every Patient Optimised.

AdaptivCRT

ASSESSESINTRINSIC

CONDUCTION

Device A

Device B

Reduces skin pressure by 30% vs. non-contoured devices17

Using a proprietary comparative Shape Pressure Analysis, Viva XT CRT-D IS1/DF4 with PhysioCurve design had overall reduced skin pressure of 30% vs. non-contoured CRT-D IS1/DF4 devices.

New Physiologic Shape with No Compromises12,16

* Pressure contour plots are scaled relative to each other: header to header, device body to device body. The device body pressure uses an enhanced scaling to demonstrate the pressure differences across the device body; therefore actual pressure is not relative to the header pressure.

Medtronic Viva XT with PhysioCurve

PhysioCurve® Design for Patient Comfort 17

• With one additional year longevity and 35 J output12,16*

• Maintains 35 J output for ALL shocks12

* Assumptions: As compared to Protecta® XT CRT-D 600 Ohm, pre-arrhythmia EGM storage ON for 6 months RA/RV Pacing % = 15%/50% RA/RV Pacing Amplitudes: 2.5 v/2.5 v LV Pacing Amplitude: 3.0 v LV Pacing 100%

Viva XT CRT-D

• Skin pressure is increased over smaller radius curves (red)16

Device A Device B

• The larger radius contour of Viva XT spreads the pressure over a broader area (dark blue)17

(See the images on the page to the right for more detail)

Viva XT CRT-D

References

1 Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.

2 Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.

3 Abraham WT, Young JB, León AR, et al. Effects of cardiac resynchronization on disease progression in patients with left ventricular systolic dysfunction, an indication for an implantable cardioverter-defibrillator, and mildly symptomatic chronic heart failure.Circulation. November 2, 2004;110(18):2864-2868.

4 Chung ES, Leon AR, Tavazzi L, et al. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. May 20, 2008;117(20):2608-2616.

5 Abraham WT, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. Volume 2, Issue 5, Supplement, May 2005, page S65.

6 Abraham WT, et al. Results from the FREEDOM Trial – Assess the Safety and Efficacy of Frequent Optimization of Cardiac Resynchronization Therapy. SP08. Late-Breaking Clinical Trials, HRS 2010. Denver, Colorado.

7 Mullens W, Grimm RA, Verga T, et al. Insights from a cardiac resynchronization optimization clinic as part of a heart failure disease management program. JACC. March 3, 2009; 53(9):765-773.

8 Singh JP, Hummel JD, Coppess MA. Left Ventricular Lead Location: Do We Know Where We Are? Heart Rhythm. 2012 12-A-8157-HRS.

9 Volosin KJ, Exner DV, Wathen MS, et al. Combining shock reduction strategies to enhance ICD therapy: a role for computer modeling. J Cardiovasc Electrophysiol. March 2011;22(3):280-289.

10 Whellan DJ, Ousdigian KT, Al-Khatib SM, et al, for the PARTNERS Study Investigators. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol. April 27, 2010;55(17):1803-1810.

11 Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH, and the CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH, and the CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH, and the CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH, and the 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. Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. 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):1181-1190.

12 Medtronic Viva XT CRT-D manual.

13 Martin DO, Lemke B, Birnie D, et al. Investigation of a Novel Algorithm for Synchronized Left Ventricular Pacing and Martin DO, Lemke B, Birnie D, et al. Investigation of a Novel Algorithm for Synchronized Left Ventricular Pacing and Martin DO, Lemke B, Birnie D, et al. Investigation of a Novel Algorithm for Synchronized Left Ventricular Pacing and Martin DO, Lemke B, Birnie D, et al. Investigation of a Novel Algorithm for Synchronized Left Ventricular Pacing and Ambulatory Optimization of Cardiac Resynchronization Therapy. Ambulatory Optimization of Cardiac Resynchronization Therapy. Ambulatory Optimization of Cardiac Resynchronization Therapy. Ambulatory Optimization of Cardiac Resynchronization Therapy. Heart Rhythm. October 2012 (in press).

14141414 Singh JP, Shen J, Chung. ES. Clinical response with Adaptive CRT algorithm compared with echo guided AV optimization: a Singh JP, Shen J, Chung. ES. Clinical response with Adaptive CRT algorithm compared with echo guided AV optimization: a Singh JP, Shen J, Chung. ES. Clinical response with Adaptive CRT algorithm compared with echo guided AV optimization: a Singh JP, Shen J, Chung. ES. Clinical response with Adaptive CRT algorithm compared with echo guided AV optimization: a propensity score analysis of multi-center trials. Presentation at European Society of Cardiology Congress August 2012.

15 Sweeney MO, EllenbogenKA, Casavant D, et al. Multicenter, prospective randomized safety and efficacy study of a new atrial-based managed ventricular pacing mode (MVP) in dual chamber ICDs. J Cardiovasc Electrophysiol. August 2005;16(8):811-817.

16 Sawchuk R, Younker G, Projected Service Life: ACRT Longevity Improvement over Protecta. Medtronic data on file. August 2013.Sawchuk R, Younker G, Projected Service Life: ACRT Longevity Improvement over Protecta. Medtronic data on file. August 2013.Sawchuk R, Younker G, Projected Service Life: ACRT Longevity Improvement over Protecta. Medtronic data on file. August 2013.Sawchuk R, Younker G, Projected Service Life: ACRT Longevity Improvement over Protecta. Medtronic data on file. August 2013.

17 Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.

Viva® XT CRT-Dwith AdaptivCRT® Algorithm

Every Patient Optimised. Every Minute.