Viva XT Brochure - 201203539IEp3

Every Patient Optimised. Every Minute.
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

Fluid Status Monitoring
OptiVol 2.0
PhysioCurve Design
Brief Statement See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.
UC201203539 IE Medtronic 2012. All Rights Reserved. Printed in Europe
www.medtronic.eu
Europe Medtronic International Trading Srl Route du Molliau 31 Case postale CH-1131 Tolochenaz Tel: +41 (0)21 802 70 00 Fax: +41 (0)21 802 79 00 United Kingdom/Ireland Medtronic Limited Building 9 Croxley Green Business Park Hatters Lane Watford Herts WD18 8WW www.medtronic.co.uk Tel: +44 (0)1923 212213 Fax: +44 (0)1923 241004
Viva XT CRT-D
with AdaptivCRT Algorithm
Viva XT CRT-D
CRT has greatly benefited heart failure patients1-3
Decreased mortality Improved quality of life Reduced hospitalisation rates
Optimise Therapy Benefits.

At Every Stage of Care.
Up to one-third of patients do not experience 1-6 the full benefit of CRT

100% 90% 80% % Improved Clinical Composite Score 70% 60% 50% 40% 30% 20% 10% 0%
MIRACLE1 MIRACLE ICD2 MIRACLE II ICD3 PROSPECT4 InSync III Marquis,*,5 FREEDOM6
67% 52% 58%
69%
67%
67%
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
*AV optimised only
There Are Many Drivers for CRT Non-Response

Potential Reasons for Suboptimal CRT Response7
50% 45% Percentage of Nonresponder Patients with These Findings 40% 35% 30% 25% 20% 15% 10% 5% 0%
Suboptimal AV Timing Arrhythmia Anemia Suboptimal LV Lead Position < 90% Suboptimal Persistent Underlying Biventricular Medical Mechanical Narrow Pacing Therapy Dyssynchrony QRS Compliance Primary RV Issues Dysfunction
Viva XT CRT-D
A New Standard in CRT

Dynamic Physiologic CRT, which promotes intrinsic RV conduction12 Reduces RV pacing and increases longevity for patients with normal AV conduction12
AdaptivCRT
12-14
A 12% Absolute Higher CRT Response Rate

Achieved with AdaptivCRT compared to Historical CRT Trials14
15% % Response Improved In Adaptive CRT Trial
Dual Chamber Pacing Restore AV synchrony
MVP Mode Algorithm to reduce unnecessary RV pacing15
12%
10%
Over 50 Years
of Pacing Leadership
AdaptivCRT Algorithm
A New Standard in CRT
5%
Rate Response Re-establish chronotropic competence
CRT Resynchronize both ventricles1
0%
[95% CI: 2.7% to 19.2%]
*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,**.
** AV optimised only
AdaptivCRT
Unique minute-to-minute optimisation of CRT pacing method and AV/VV delays12
atient Optimis P y r e ed. Ev
Normal AV Conduction
Prolonged AV Conduction
ASSESSES INTRINSIC CONDUCTION
Adaptive LV pacing
Adaptive BiV pacing
Every Minute.
Viva XT CRT-D
New Physiologic Shape with No Compromises

12,16
Reduces skin pressure by 30% vs. non-contoured devices

Medtronic
Viva XT with PhysioCurve
17
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.
Curve Design for Patient Comf o i s y h P ort
17
With one additional year longevity and 35 J output12,16* Maintains 35 J output for ALL shocks12
Device A
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)
Device B
* 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% * 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.
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. 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. Abraham WT, Young JB, Len 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. 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. 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. 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. 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. Singh JP, Hummel JD, Coppess MA. Left Ventricular Lead Location: Do We Know Where We Are? Heart Rhythm. 2012 12-A-8157-HRS. 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. 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. 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. J Am Coll Cardiol. March 8, 2011;57(10):1181-1190. Medtronic Viva XT CRT-D manual. 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. Heart Rhythm. October 2012 (in press). 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. 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. Sawchuk R, Younker G, Projected Service Life: ACRT Longevity Improvement over Protecta. Medtronic data on file. August 2013. Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.
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Viva XT CRT-D
with AdaptivCRT Algorithm

Viva XT Brochure - 201203539IEp3

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Every Patient Optimised. Every Minute.

AdaptivCRT Algorithm Ensure CRT Suite with CardioSync

SmartShock Technology 2.0 Atrial Therapies

UC201203539 IE Medtronic 2012. All Rights Reserved. Printed in Europe

Optimise Therapy Benefits.

Up to one-third of patients do not experience 1-6 the full benefit of CRT

67% 52% 58%

*AV optimised only

There Are Many Drivers for CRT Non-Response

Every Patient Optimised. Every Minute.

A New Standard in CRT

A 12% Absolute Higher CRT Response Rate

Dual Chamber Pacing Restore AV synchrony

MVP Mode Algorithm to reduce unnecessary RV pacing15

A New Standard in CRT

Rate Response Re-establish chronotropic competence

CRT Resynchronize both ventricles1

Every Patient Optimised. Every Minute.

atient Optimis P y r e ed. Ev

ASSESSES INTRINSIC CONDUCTION

Adaptive BiV pacing

New Physiologic Shape with No Compromises

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

Curve Design for Patient Comf o i s y h P ort

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

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