Advisa MRI™ENGINEERED WITH SURESCAN MRI TECHNOLOGY

SureScan

I N N O V A T I O NWhat should you expect in today’s leading-edge pacing system? A system that can benefit patients tomorrow as well.

The Advisa MRI™ pacing system is designed for safe

access to MRI diagnostic imaging with SureScan™

and unparalleled disease insight and management

for your patients today. Plus it has the tools to

diagnose and manage the co-morbidities they

may develop tomorrow. Our most advanced

Advisa MRI pacing system provides your patients

unsurpassed capabilities. Innovative features like

MVP®, OptiVol®, digital diagnostics and a complete

suite of atrial therapies.

Innovation, Sophistication, Simplicity.With no compromise.

Advisa MRI™ Leading edge innovation for managing various patient conditions and co-morbidities

N O C O M P R O M I S EA pacemaker should not lead to unnecessary

right ventricular pacing which has been linked

to increased risk of Atrial Fibrillation and Heart

Failure, nor should it prevent your patient from

undergoing an essential MRI. The Advisa MRI™

pacing system offers technological advances

that will not compromise the future care

of your patients.

SureScan™ is designed for safe access to MRI, an unparalleled diagnostic imaging

• For millions of patients with cardiac devices,

MRI scans are unsafe and contraindicated

• 50%-75% of patients with an implantable

cardiac device will need an MRI scan over the

lifetime of their device1

• SureScan pacing systems are the first pacing

systems – consisting of the pacemaker and

leads – that are designed, tested, and

CE Mark-approved for use with MRI when

used according to labeling.

Managed Ventricular Pacing (MVP®)

Intrinsic conduction when you have it, the safety of pacing when you need it.

• Unnecessary right ventricular (RV) pacing

increases the risk of Atrial Fibrillation (AF), Heart

Failure hospitalisation, and mortality2-4

• The ESC Guidelines state that in the selection

of pacing mode and device, “the trend

is towards dual chamber pacing with

minimisation of right ventricular stimulation”5

and the ACC/AHA/HRS guidelines also

recognised the importance of minimising

unnecessary RV pacing

• Managed Ventricular Pacing (MVP®) is proven

to reduce unnecessary RV pacing by 99%*6,7

• A strategy of minimising ventricular pacing

led to a 40% reduction in the relative risk

of developing persistent AF compared to

conventional dual chamber pacing4

No compromise for co-morbidity management today or in the future

SAVE PACe TRIAL4

Years from Implant/Patients Remaining

0.0 0.5 1.0 1.5 2.0 2.5 3.0

Free

dom

from

per

sist

ent A

F

1,065 728 587 424 249 115840

0.0

0.7

0.8

0.9

1.0

Conventional dual chamber pacingDual chamber minimal ventricular pacing

p = 0.009

s o p h i s t i c a t i o n

Cardiac Compass® Trends provide clear

information for detecting atrial arrhythmias and for

rapid decision making.

• 14 months of trended data helps monitor results

of device and drug therapy changes

• Daily AF burden helps assess rhythm control

• Ventricular rate during AT/AF helps assess

rate control

• Daily percent ventricular pacing helps assess

reduction of unnecessary pacing

• AF documentation identifies asymptomatic

arrhythmias

22 minutes of dual channel high quality stored EGM

• Detection and classification of arrhythmias based

on highly sensitive and specific PR Logic algorithm

• Direct insight into onset, morphology, and

termination of arrhythmias

How many of your pacemaker patients might develop Atrial Fibrillation or Heart Failure throughout their lives?

Jan 2010Nov 2009Sep 2009Jul 2009May 2009Mar 2009Jan 2009

P = ProgramI = Interrogate_ = Remote

IPPPPP

AT/AF total hours/day

048

12162024

V. rate during AT/AF(bpm)

max/dayavg/day

<50

100

150

>200

% Pacing/dayAtrialVentricular

0255075

100

Avg V. rate (bpm)DayNight

<406080

100>120

Patient activity hours/day

01234

Heart rate variability(ms)

<4080

120160

>200

OptiVol �uid index

OptiVol �uid index is an accumulation of the di�erence between the daily and reference impedance.

OptiVolthreshold

Fluid 0

40

80

120

160

>200

Thoracic impedance(ohms)

DailyReference

Jan 2010Nov 2009Sep 2009Jul 2009May 2009Mar 2009Jan 200940

50

60

70

80

90

>100

CARDIAC COMPASS REPORT

OPTIVOL INTRATHORACIC IMPEDANCE MEASUREMENT

OptiVol® Fluid Status Monitoring, together with the Heart Failure Management

Report,8–12† track and monitor fluid changes using

intrathoracic impedance measurements.

• OptiVol automatically monitors fluid status to

predict worsening Heart Failure13,14

• OptiVol can be used to risk stratify your HF patients

for more frequent monitoring13,14

• Available on Medtronic CareLink® Network,

enabling a fluid status check from

a patient’s home

Precise and advanced diagnostics in the Advisa MRI™ pacing system provide you a

clear picture of your patient’s condition, now and as it evolves.

Carelink® Network

• CareLink Network allows remote device follow-up

by transmitting comprehensive arrhythmia and

diagnostic data right to your clinic

• Detailed EGM™ Viewer, patient activated

EGM storage, displays symptomatic episodes

PATIENT-ACTIVATED EGM STORAGE IS ACCESSED REMOTELY ON THE MEDTRONIC CARELINK NETWORK.

Episode ID#19Can to RVring

Interval Markers

A-A (ms)

V-V (ms)

Date16-Jul-2009

VS

AS

AS

AS

AS

AS

AS

AS

VS

VS

VS

VS

VS

VS7

60

760

760

760

760

760

760

760

760

760

760

760

Patient Mark (Symptom)

Time10:07

(1mV)

s o p h i s t i c a t i o n

Atrial tachyarrhythmia tools help in the

early detection and management of AF.

• Antitachycardia Pacing (ATP) Therapies

recognise treatable atrial tachycardias

quickly and deliver painless ATP to restore

sinus rhythm15–16

• A complete set of additional atrial

management features may reduce onset and

symptoms:

– Atrial Preference Pacing (APP) may suppress

ectopic beats which can trigger AF

– Atrial Rate Stabilisation (ARS) may, after

a Premature Atrial Contraction (PAC),

eliminate the short-long-short atrial

activation sequence that may precede an

arrhythmia onset

– Post Mode-switch Overdrive Pacing (PMOP)

may help prevent the early recurrence of an

atrial tachyarrhythmia

– Conducted AF Response may reduce

symptoms of AT and AF

Rate Drop Response identifies abrupt

cardiac slowing and responds by pacing the

heart at an elevated rate. This may reduce the

frequency of syncopal episodes in patients with

apparent cardioinhibitory Vasovagal Syncope.17

High Upper Tracking Rates up to 210 bpm

are beneficial for your pediatric patients as well

as young and active patients.

Sophisticated therapies like Atrial Antitachycardia Pacing and Rate Drop

Response are ready when your patient needs it.

How many of your patients suffer from Vasovagal Syncope or Atrial Fibrillation?

ATRIAL ANTITACHYCARDIA PACING

s i m p l i c i t yFull Automaticity - proven safe, simple, and accurate18

With the Advisa MRI™ pacing system, leading-

edge innovation and sophistication does

not mean complexity. Rather, we’ve built in

features for surprising simplicity, offering safety

for your patients and ease of use for you.

• Fully automatic pacemaker follow-up

means more time with patients, less time

with devices

• Atrial and Ventricular Capture Management™

(ACM and VCM) provide confidence in your

patients’ safety with automatic threshold

measurements and adjustments

• TherapyGuide® offers easy, patient tailored

nominal programming

The Advisa MRI™ Pacing System is right for your patients

now and will be right for them in the future – even if

they develop comorbidities like Heart Failure or Atrial

Tachyarrhythmias, or require an MRI.

Innovation, Sophistication, Simplicity.With no compromise.

Does the most advanced technology have to be complicated?

Digital Signal

Processing Inside

DEVICE CHECK – FULLY AUTOMATIC

BATTERY

LEAD IMPEDANCE

PACING THRESHOLD

SENSING

CLINICAL CHECK – FULLY AUTOMATIC

PACING MODE

VENTRICULAR AND ATRIAL ARRHYTHMIA

PACING/SENSING

RELEVANT OBSERVATIONS

ROUTINE FOLLOW-UP DONE WHEN YOUR PATIENT ARRIVES

ALL KEY INFORMATION ON ONE QUICK LOOK™ II SCREEN

THERAPY GUIDE

References1. Kalin R, Stanton MS. Current clinical

issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):326-328.

2. Extrapolated from Sweeney MO, Hellkamp AS, Ellenbogen KA, et al, for the MOde Selection Trial (MOST) Investigators. 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.

3. Wilkoff BL, Cook JR, Epstein AE, et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. December 25, 2002;288(24):3115-3123.

4. Sweeney MO, Bank AJ, Nsah E, et al. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. September 6, 2007;357(10):1000-1008.

5. Vardas PE, Auricchio A, Blanc JJ, et al. ESC Guidelines for Cardiac Pacing and Cardiac Resynchronization Therapy. Eur Heart J. September 2007;28(18):2256-2295.

6. Gillis AM, Pürerfellner H, Israel CW, et al. Reduction of unnecessary ventricular pacing due to the Managed Ventricular Pacing (MVP) mode in pacemaker patients: benefit for both sinus node disease and AV block indications. Heart Rhythm. 2005;Abstract B21-1.

7. Sweeney MO, Ellenbogen KA, 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.

8. Yu CM, Wang L, Chau E, et al. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. August 9, 2005;112(6):841-848.

9. Small RS. Integrating device-based monitoring into clinical practice: insights from a large heart failure clinic. Am J Cardiol. May 21, 2007;99(10A):17G 22G.

10. Germany R, Murray C. Use of device diagnostics in the outpatient management of heart failure. Am J Cardiol. May 21, 2007;99(10A):11G-16G.

11. Small R, Tang W, Wickemeyer W, et al. Managing heart failure patients with intra-thoracic impedance monitoring: a multi-center US evaluation. J Card Fail. August 2007;13(6):S113-S114.

12. Small R, Rathman L, Repoley J. Can monitoring heart failure status with intrathoracic impedance reduce the rate of heart failure hospitalization? AFSA 2008. Abstract.

13. Whellan DJ, Al-Khatib SM, Kloosterman EM, et al. Changes in intrathoracic fluid index predict subsequent adverse events: Results of the multi-site program to access and review Trending INformation and Evaluate CoRelation to Symptoms in Patients with Heart Failure (PARTNERS HF) Trial. J Card Fail. 2008;14(9):799.

14. Small RS, Wickemeyer W, Germany R, et al. Changes in intrathoracic impedance are associated with subsequent risk of hospitalizations for acute decompensated heart failure: clinical utility of implanted device monitoring without a patient alert. J Card Fail. 2009. In press.

15. Lee M, Weachter R, Pollak S, et al. Can preventive and antitachycardia pacing reduce the frequency and burden of atrial tachyarrhythmias? The ATTEST study results. PACE 2002 Apr;25 (4,PtII):541

16. Israel C. Success rate of automatic atrial antitachycardia pacing by a pacemaker implanted in patients with paroxysmal and persistent atrial tachyarrhythmia. Abstract 3454. Circulation. October 31,2000;102, (Suppl II, No. 18).

17. Benditt D.G. et al. ‘Rate-Drop Response’ Cardiac Pacing for Vasovagal Syncope. J. Interv Card Electrophysiol 1999 Mar; 3(1): 27-33

18. EnPulse PMA-s Clinical Report 2003. Data on file. Medtronic, Inc.

*median number†OptiVol is adjunctive to existing evaluation and assessment tools. Photos used with the kind permission of the Siemens AG.

www.medtronic.eu

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