1

Everything and MRI

ACCENT MRI PACEMAKER AND TENDRIL MRI LEAD ADVANTAGES

Wireless full featured pacing therapy andState-of-the-art

Wireless, full-featured pacing therapy and proven lead technology and MRI scanning compatibility1

SafeFull-body MRI (1,5 Tesla) scans with no zone restrictions1 and high-power, whole-body imaging with SAR* up to 4 W/kg for superior quality

SimplifiedUnique SJM MRI Activator™ device enables and disables pre-programmed MRI settings pre- and post scan for increased clinic efficiencypost-scan for increased clinic efficiency

1. MRI conditional pacemaker system; an MRI conditional pacing system is conditionally

*Specific Absorption Rate

safe for use in the MRI environment when used according to the instructions in this manual. See the St. Jude Medical MRI Procedure information document prior to performing an MRI scan: www.SJMprofessional.com/MRI

2

Clinical Need: Managing the Diagnostic Needs of Patients with Pacemakers MRI is a preferred diagnostic tool for patients who experience stroke,

cancer, spine and neurologic diseases. Up to 75% of pacemaker patients could benefit from MRI scans Up to 75% of pacemaker patients could benefit from MRI scans

during the lifetime of their device1

A recent study indicated physicians may request MRI procedures for 17% of their patients within 12 months of implant2for 17% of their patients within 12 months of implant

Solution St. Jude Medical offers a MRI

conditional pacing system without compromise—no zone restrictions3

and high-power imaging for superior

1. Kalin R and Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator

quality.

patients. PACE 2005;28:326–8.2. Strach K et al. Low-field magnetic resonance imaging: increased safety for pacemaker patients?

Europace 2010;12:952-60. 3. MRI conditional pacemaker system; an MRI conditional pacing system is conditionally safe for

use in the MRI environment when used according to the instructions in this manual. See the St. Jude Medical MRI Procedure information document prior to performing an MRI scan: www.SJMprofessional.com/MRI

3

Clinical Need: Lead Reliability An MRI conditional pacing lead must be able to withstand the An MRI conditional pacing lead must be able to withstand the

magnetic forces, gradients, and RF energy present during scanning and the harsh environment of the human body.

Solution The Tendril MRI lead offers

unique design advantages 6 6 F lead bodyto ensure MRI scanning capability1.

6,6 F lead bodyfor ease of implant (8 F minimum introducer)

Special filter to prevent tissue heating and unintended cardiac stimulation

Optim™ insulationfor long-term reliability

Standard inner and outer coils for proven reliability and performance

1 MRI conditional pacemaker system; an MRI conditional pacing system is

Silicone inner tubing for protection of coils

4

1. MRI conditional pacemaker system; an MRI conditional pacing system is conditionally safe for use in the MRI environment when used according to the instructions in this manual. See the St. Jude Medical MRI Procedure information document prior to performing an MRI scan: www.SJMprofessional.com/MRI

Tendril MRI™ Lead Body Construction Tendril MRI™ lead body

construction is very similar to other St. Jude Medical standardother St. Jude Medical standard Tendril™ leads (non-MRI), including lead handling characteristicscharacteristics Comparable coil construction Similar helix extension &Similar helix extension &

retraction performance (10 -15 turns)

Tendril MRI™ lead

Tendril™ lead

(non MRI)(non-MRI)

5

Proven, Long-term Lead ReliabilityThe Tendril MRI™ lead from St. Jude Medical is built on the proven Tendril lead platform and features durable Optim insulation.

1. MRI conditional pacemaker system; an MRI conditional pacing system is conditionally safe for use in the MRI environment when used according to the instructions in this

6

manual. See the St. Jude Medical MRI Procedure information document prior to performing an MRI scan: www.SJMprofessional.com/MRI

Clinical Need: Easy Pacemaker Programming; Pre- and Post-MRI Scan MRI conditional pacemakers must be temporarily set to MRI settings

prior to a scan and restored to permanent settings following the scan. Scanning can range from 30 to 90 minutes pending clinical schedules Scanning can range from 30 to 90 minutes, pending clinical schedules May require physicians to be available at unpredictable hours Increased burden to support programming needs which will grow as

MRI devices become standard practiceMRI devices become standard practice

SolutionOnly St. Jude Medical offers the

The SJM MRI Activator device fits in the palm of the hand, has a simple yes-no function and easy-to-read displays.

easy-to-use SJM MRI Activator device designed to enable and disable pre-programmed MRI settings seamlessly for a moresettings seamlessly for a more efficient workflow in both the cardiology clinic and radiology center.

7

Simplified and Quick Access to MRI SettingsfIncrease patient safety by reducing time in asynchronous or

non-pacing modes

Traditional MRI patient workflow

St. Jude Medical streamlined MRI patient workflow

1

81. The SJM MRI Activator device is designed to enable/disable pre-programmed MRI settings

quickly and easily pre- and post-scan; do not take the SJM MRI Activator device into the MRI magnet/scanner room.

Innovative Design Optimizes Safety & UsePotential MRI Risks Magnetic Field SJM Design Solution

Tissue damage/loss of sensing or pacing capture

RF coils • Filters added to pacing lead tip prevent RF currents from heating and damaging tissue;filters do not affect sensing and pacing signals p g p g gtransmitted through the lead (to and from the pacemaker, respectively)

Cardiac arrhythmias Gradient field/RF coils New filter board added to reduce the risk of and inhibition of pacing support

cardiac stimulation due to rectification; filter board protects all electronic components

• Feed thru filtering properties refined to reduce risk of gradient induced cardiac stimulation that could result in arrhythmiascould result in arrhythmias

• Modified pacer circuitry prevents gradient-induced cardiac stimulations & pacing pulse cancellation

• Special MRI pacing parameters optimized for f i d i MRI isafe pacing during MRI scanning

Force, torque or damage to mechanical integrity

Static field Circuitry changes prevent MRI forcesfrom disrupting device operation

Limited use of ferromagnetic components d tibilit t ti tt tidecreases susceptibility to magnetic attraction

9

“No Compromise” MRI Conditional Pacing System

Clinical Features Accent MRI™ Pacing System

Full-body MRI (1,5 Tesla) scans with no zone restrictions*

High-power, whole-body imaging (SAR up to 4 W/kg) for superior images

Pacing lead specifically designed for MRI environment on a proven design platform

SJM MRI Activator™ device for simplifiedSJM MRI Activator device for simplifiedworkflow & increased efficiency

*MRI conditional pacemaker system; an MRI conditional pacing system is conditionally safe

Copyright 2011 St Jude Medical. For internal use only

MRI conditional pacemaker system; an MRI conditional pacing system is conditionally safefor use in the MRI environment when used according to the instructions in this manual. See the St. Jude Medical MRI Procedure Information document prior to performing an MRI scan: www.SJMprofessional.com/MRI.

SummaryAccent MRI Pacemaker System is… State-of-the-Art

Wireless full featured pacing therapy for more efficient Wireless, full-featured pacing therapy for more efficient patient management and proven lead technology forlong-term reliability—in addition to MRI compatibility

S f Safe Full-body MRI (1,5 Tesla) scans with no zone restrictions1

and high-power, whole-body imaging with SAR up to 4W/kg for superior qualityfor superior quality

Simplified Unique SJM MRI Activator device enables and disables

pre-programmed MRI settings pre- and post-can for increased clinic efficiency

1. MRI conditional pacemaker system; an MRI conditional pacing system is conditionally f f

11

safe for use in the MRI environment when used according to the instructions in this manual. See the St. Jude Medical MRI Procedure information document prior to performing an MRI scan: www.SJMprofessional.com/MRI

Accent MRI DR Pacemaker Specifications

Accent MRI RFDR PM2224

Accent MRI Inductive DR PM2124DR - PM2224 DR - PM2124

Size (H x W x D) 52 x 53 x 6 52 x 53 x 6

Weight (g) 24 23

Volume (cc) 13,1 13,1

Longevity (years) 9,1* 9,4*

MRI Conditional Yes YesLabeling Yes Yes

*A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% DDD pacing @ 60 bpm; AutoCapture™ Pacing System OFF; SEGMs ON

12

Accent MRI SR Pacemaker Specifications

Accent MRI RFSR PM1224

Accent MRI Inductive SR PM1124SR - PM1224 SR - PM1124

Size(H x W x D) 52 x 53 x 6 46 x 52 x 6

Weight (g) 24 22

Volume (cc) 13,1 12,0

Longevity (years) 13,7* 14,2*

MRI Conditional Yes Yes

*V = 2,5 V @ 0,4 ms; 500 ohms; 100% VVI pacing @ 60 bpm; AutoCapture™ Pacing System OFF; SEGMs ON

Labeling Yes Yes

13

Tendril MRI™ Lead SpecificationsDesign Feature Specifications

Minimum introducer size without guidewire* 8 F (6,6 F lead body; 8 F minimum introducer)g

Type of lead Active-fixation; bipolar; steroid-eluting

Connector IS-1 bipolar

Lengths 46; 52; and 58 cm

Tip-to-ring spacing 10 mm

Mapping With TiN-coated platinum iridium helix Mapping p(1,8 mm extension)

Inner insulation Silicone rubber

Outer insulation Optim™ lead insulationOuter insulation Optim lead insulation

* Minimum introducer size with guidewire = 10,5 F

14

Preparing Patients withPreparing Patients with Pacemakers for an MRI Scan

Steps for Pre-approving Patients for an MRI

Step 1 – Save MRI settings that best suit your patient Programming MRI Settings In the “Parameters” section,

press the “MRI Settings” tab You can choose from the You can choose from the

following modes: Asynchronous pacing

(DOO, VOO, AOO) Pacing off

Press “Test MRI Settings”Press Test MRI Settings button to see how the patient responds

16

Steps for Pre-approving Patients for an MRI

Verify the MRI Checklist Press the “Setup MRI Activator”

b tt t i t t thbutton to navigate to the “MRI Checklist” screen

Verify conditions on theVerify conditions on the MRI Checklist Note that abandoned

leads lead adapters orleads, lead adapters or lead extenders are contraindications for an MRI scanan MRI scan

17

Steps for Pre-approving Patients for an MRI Approving Patients for an MRI Enable the pre-approval

t th MRI A ti tto use the MRI Activator device by pressing the “Enable MRI Activator” button MRI Settings will only go

into effect after the MRI to e ect a te t eActivator devices is used to turn them on

18

Steps for Pre-approving Patients for an MRI

Step 2 – Verify Patient has ID Card Reinforce that your patient should carry

his/her ID card at all times

19

Steps for Pre-approving Patients for an MRI

Step 3 – Using the SJM MRI Activator™ Device at the MRI Clinic

U th SJM MRI A ti t d i t t th Use the SJM MRI Activator device to put the MRI conditional pacemaker in MRI settings

Safely scan the patientSafely scan the patient After the scan, use the SJM MRI Activator device

to disable MRI settings and restore normal pacemaker operation

Patient needs an MRI scan

Patient has an

MRI scan1

Patient goes home

201. The SJM MRI Activator device is designed to enable/disable pre-programmed MRI settings

quickly and easily pre- and post-scan; do not take the SJM MRI Activator device into the MRI magnet/scanner room.

X-Ray Verification To verify that a patient has a St. Jude Medical MRI

pacemaker, you may use X-ray identification, confirming that the pacemaker and the lead are appropriate.that the pacemaker and the lead are appropriate. Radiopaque markers will show if the patient has an appropriate system for an MRI scan

St. Jude Medical Identifier

Device MRI Symbol

Easily identifiable i diunique radiopaque

markers

21

R di l C tRadiology Center

Radiology CenterSt. Jude Medical has developed an MRI conditional pacing system to allow safe MRI diagnostic imaging. Patients may undergo a scan in a 1,5 Tesla and 4 W/kg

MRI scanner Horizontal, closed-bore scanner Normal operating mode or first-level controlled operating modep g p g

Whole body specific absorption rate (SAR) up to 4.0 W/kg and head SAR up to 3.2 W/kg

Maximum gradient slew rate of 200 T/m/s per axis Refer to MRISafety.com for all conditions for use

Use the SJM MRI Activator device to put the pacemaker into MRI Conditional settingsg Do not bring the SJM MRI Activator device into Zone IV as

defined by the American College of Radiology Product information available at MRISafety.comProduct information available at MRISafety.com

23

Steps for Scanning a Pacemaker Patient

Step 1 – Verify Verify that the patient has a St. Jude Medical MRI

Conditional pacing system

24

Steps for Scanning a Pacemaker Patient

Step 2 – Position Position the SJM MRI

Activator™ device over the implanted pacemaker

25

Steps for Scanning a Pacemaker Patient

Step 3 – Before the Scan

26

Steps for Scanning a Pacemaker Patient

Step 4 – After the Scan

27

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2011 St. Jude Medical, Inc. All Rights Reserved.

28