FDA approved for MRI useThe first pacing system to break the image barrier

The Revo MRI SureScan pacing system is MR Conditional designed to allow patients to undergo MRI under the specified conditions for use. A complete system, consisting of a Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI® SureScan leads is required for use in the MRI environment.

The First and Only Pacing SystemFDA Approved for MRI Use

Specifically engineered for MRI safety, with reliable lead technology and a proven pacemaker platform – this is state-of-the-art pacing.

Now your patients get proven cardiac care with MRI access.

Meeting the Need for MRIPacemaker Implants in an Aging Population

• The number of pacemakers currently implanted in the United States is approximately 1.5 million1,2

Elderly patients are the primary users of MRI: individuals over age 65 are twice as likely to need an MRI compared to younger recipients.3

Average Age of Pacemaker Patient

13%Ages 25-64

86%Age 65+

1 Kalin R, Stanton MS. PACE. 2005;28:326-328.2 Zhan C, et al. Gen Intern Med. 2008;23:13-19. 3 Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment – a global strategic business report. San Jose, CA. 2002.

Part of Comprehensive Patient Care• Now, for the first time, you can implant a state-of-

the-art pacing system to provide proven cardiac care AND MRI access when your patients need it

Number of Comorbidities in Pacemaker Patients

• Given that 85% of all pacemaker patients have one or more comorbidities, facilitating comprehensive multispecialty care is important in today’s environment

Medical and Surgical Specialties Rely on MRI for Diagnosis

• Your choice can affect their decisions and diagnostic capabilities

15%0 comorbidities

30%1 comorbidity

28%2 comorbidities

27%3 or more

comorbidities

Opthalmology

Otolaryngology

Neurosurgery

Neurology

Cardiothoracic Surgery

Surgical Oncology

Nephrology

Gynecologic Oncology

Urology

Rheumatology

Oncology

Radiation Oncology

Interventional Radiology

Gastrointestinal Surgery

Orthopedic Surgery

Vascular Surgery

85%1 1 or more comorbidities

1 Kalin R, Stanton MS. PACE. 2005;28:326-328.

Prevalence of Common Comorbiditiesin the Pacemaker Patient PopulationThe Prevalence of Common Comorbidities Increases Rapidly Over Age 65.1-3

MRI Is the Gold Standard Diagnostic Tool forNeurologists, Oncologists, and Orthopedic Surgeons,Whose Patients Are Often Over 65 Years of Age.4

• MRI is unmatched in its ability to accurately visualize soft tissue

• It is estimated that 50 to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device5

The Most Common Reasons for MRI Referral AreMusculoskeletal and Neurological Symptoms.6

Medicare records show that in patients > 65 years of age withan implanted pacemaker:

• 34% have spine and intervertebral disc disease7

• 36% have chronic pain of wrist, foot, ankle, or elbow7

• 14% suffer from injury or trauma to the spine, knee, or shoulder7

1 National Cancer Institute April 2009. US estimated complete prevalence (including counts) by age on 1/1/2006. Based on November 2008 SEER data submission; DCCPS, Surveillance Research Program, Statistical Research and Applications Branch.

2 Lawrence RC, et al. Arthritis Rheum. 1998;41:778-799.3 American Heart Association. Heart Disease and Stroke Statistics – 2010 Update: Learn and Live.

Prevalence of stroke by age and sex (NHANES: 2003-2006). 4 Magnetic Resonance Imaging (MRI) Equipment – A global Strategic Business Report, Global

Industry Analysts, Inc., San Jose, CA 2002.5 Kalin R, Stanton MS. PACE. 2005;28:326-328.6 Medical Imaging Survey, 2009.7 Medicare Fee-for-Service Review, 2007.

Field

Impact Static Gradient RF

Lead HeatingThe conductive pacing lead acts as an antenna, picking up radiofrequency energy. A portion of this energy is dissipated as heat in the cardiac tissue near the tip electrode.

Tissue damage may affect pacing therapy.

Unintended Cardiac StimulationThe gradient and radiofrequency fields will induce voltages in pacemaker leads that will be applied to the pacing lead electrodes. If these voltage pulses are large enough, they may directly stimulate the heart.

May lead to a single or intermittent stimulation, or sustained tachycardia.

Device InteractionsThe gradient, radiofrequency, and static fields may adversely affect the electrical operation of the pacemaker system if its operation is not protected from the effects of those fields.

Pacemaker malfunction or failure may affect pacing therapy.

Hazards and Risks of MRI with Current Pacing SystemsSince 2008, the safety and risk concerns of MRIs in cardiac device patients have been documented in 17 studies. 1-17

MRI can put pacemaker patients at risk for any of the following16:

1 Naehle CP, et al. Pacing Clin Electrophysiol. 2009;32:1526-1535. 2 Goldsher D, et al. Pacing Clin Electrophysiol. 2009;32:1355-1356.3 Gimbel JR. Europace. 2009;11:1241-1242.4 Naehle CP, et al. J Am Coll Cardiol. 2009;54:549-555. 5 Roguin A. J Am Coll Cardiol. 2009;54:556-557. 6 Mollerus M, et al. Pacing Clin Electrophysiol. 2008;31:1241-1245. 7 Pulver AF, et al. Pacing Clin Electrophysiol. 2009;32:450-456. 8 Nordbeck P, et al. Magn Reson Med. 2009;61:570-578. 9 Sutton R, et al. Trials. 2008;9:68.10 Naehle CP, et al. Radiology. 2008;249:991-1001.

11 Calcagnini G, et al. J Magn Reson Imaging. 2008;28:879-886. 12 Dyrda K, Khairy P. Expert Rev Cardiovasc Ther. 2008;6:823-832. 13 Gimbel JR. Pacing Clin Electrophysiol. 2008;31:795-801. 14 Nordbeck P, Bauer WR. Dtsch Med Wochenschr. 2008;133:624-628.[Article in German.]15 Tandri H, et al. Heart Rhythm. 2008;5:462-468. 16 Roguin A, et al. Circulation. 2004;110:475-482. 17 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System

Clinical Report, in support of FDA premarket approval.

MR Conditional Risk Information• A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan leads is required for use in the MRI environment• Any other pacing system combination may result in a hazard to the patient during an MRI scan• When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing

• Refer to the Revo MRI Pacing System Conditions for Use located in the device manuals prior to scanning a patient. Consult Medtronic’s website at www.medtronic.com or call Medtronic at 1 (800) 328-2518.

Specifically Engineered for MRI SafetyDevice Design Solutions• Input circuits optimized• Circuit design immune to interference• SureScan® Pacing Mode

– Asynchronous pacing– High pacing outputs

• The Revo MRI™ SureScan pacing system has completed clinical evaluation, regulatory review, and FDA approval; it is safe for use when used according to the MRI conditions for use as defined in the SureScan manual

• The implanted system must consist solely of a Medtronic Revo MRI SureScan Model RVDR01 device and two CapSureFix MRI® SureScan Model 5086 MRI leads

Revo MRI SureScan Pacemaker – A Pacemaker Engineered with Multiple Safety Features

• Device verification appears on pacemaker programmer screen• Automatic testing ensures only appropriate battery and impedance data are

collected during MRI• Dedicated programming mode provides additional security/backup for power

on reset (POR)• Hall sensor is immune to strong magnetic fields

Easily Identifiable, Radiopaque Icon Confirms SureScan Device Implant

Specifically Engineered for MRI SafetyLead Heating Design Solution

• Lead inner conductor coil design mitigates lead heating • 4 filar to 2 filar increases inductance and reduces heating

• Materials identical to 5076*• Model 5086MRI lead flex testing

– Connector/body

– Lead body• Model 5086MRI clinical implant

experience starting February 2007 (928 leads implanted)

*Exception of MRI Marker band and electrode coating

CapSureFix MRI® SureScan® Lead Model 5086 – A Lead Designed for MRI Use

• The state-of-the-art 5086 lead is specifically designed and engineered for safety within an MRI environment

• The 5086 lead is based on the CapSureFix® family of leads, which have been implanted in more than 1 million patients worldwide – that’s 2.5 million leads, with 99.5% reliability

Easily Identifiable, Radiopaque Icon Confirms SureScan Device Implant

Lead HeatingModel 5076 versus Model 5086 MRI

– the x-axis represents 50 anatomically relevant lead paths– the results demonstrate significant variability in lead tip heating as a function of the lead path– overall the 5086 MRI lead heats approximately 3 times less than the 5076 for most lead paths

Preclinical Research Demonstrates the Safety of Revo MRI™ Pacing System1

Testing Summary

Extensive preclinical evaluation was based on clinically relevant as well as worst-case scan conditions, using in vitro (bench) testing, in vivo (animal) testing, and computer simulations (modeling).

MRI-Induced Lead Heating

Simulations in Human Body Models Using Different Lead Combinations

• Human body models encompassed 2nd to 97th percentile of all human bodies, with ten different lead paths• Over 400,000 different lead/body combinations were analyzed to derive a minimal probability of a 0.5 V threshold

Human Body Library Lead Paths

1 Magnetic Resonance Imaging (MRI) Equipment – a global strategic business report, Global Industry Analysts, Inc. San Jose, CA. 2002.

MRI-Induced Unintended Cardiac Stimulation (UCS)

• Analysis combined a prediction for the induced voltage pulse widths and amplitudes, and an in-vivo canine study to evaluate the stimulation threshold to these pulses

• The risk of reaching the gradient stimulation range is 1/1,000,000, which remains outside the capture range

• Results confirmed that patient risk from UCS is at an acceptable level

Gradient Stimulation Strength Duration Curve

Study Design

• Multicenter, randomized, controlled clinical trial designed to evaluate the safety of the Revo MRI SureScan Pacing System, including any MRI-related complications, as well as to analyze pacing capture thresholds and sensing amplitude

• 464 patients received a SureScan pacing system and were then randomized to elective MRI or no MRI, approximately 9-12 weeks post-implant

• MRI imaging intended to represent commonly used, clinically relevant scans

Methods – Visit Schedule

Clinical Trial Demonstrates the Safetyof Revo MRI™ SureScan®1

1 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.

Clinical Trial Demonstrates the Safetyof Revo MRI™ SureScan®1

Key Results

• 100% were free of MRI-related complications (n = 211, P < 0.001)• No sustained atrial or ventricular arrhythmias, no asystole, no pacemaker output inhibition, and no electrical resets in the group

receiving MRI • Minimal changes in pacing capture thresholds, as shown on the following chart

Primary Effectiveness End Point: Atrial and Ventricular Capture Threshold

Threshold changes pre-MRI/control visit to 1-month post-MRI/control visit

1 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.

Builds Upon Medtronic Innovations

MVP® – Managed Ventricular Pacing• Exclusive technology that uses atrial pacing (AAIR) primarily, with DDD(R) pacing only when necessary

• MVP reduces unnecessary RV pacing by 99%1

ACC/AHA/HRS guidelines2 state the need to reduce unnecessary pacing as much as possible. The following studies support the guidelines:

MOST3: Every incremental 1% of unnecessary VP increases the risk for heart failure hospitalizations by 5.4%, and for AF, by 1%.

Danish II4: Even with long AV delays, the risk of AF doubles with DDD(R) pacing compared to AAI(R) with DDD(R) backup.

Gardiwal5: Patients with 72% RV pacing are at increased risk for VT/VF.

Medtronic CareLink® Network*

• The leading Internet-based, remote monitoring service for implanted devices6

• Serving nearly 500,000 patients in 3,000 clinics in the United States

* Not all devices are available on the CareLink® Network

1 Gillis AM, et al. Heart Rhythm. 2005. Abstract AB21-1.2 Epstein AE, et al. J Am Coll Cardiol. 2008;51:e1-62.3 Sweeney MO, et al. Circulation. 2003;10:2932-2937.4 Nielsen JC, et al. J Am Coll Cardiol. 2003;42:614-623.5 Gardiwal A, et al. Europace. 2008;10:358-363.6 Medtronic CareLink Metrics Database.

Revo MRI™ Pacing System – Conditions for Use

A complete SureScan® pacing system including a Revo MRI SureScanIPG and two SureScan leads is required for use in the MRI environment.Any other combination may result in a hazard to the patient during an MRIscan. The SureScan feature must be programmed to On prior to scanning apatient according to the specified conditions for use.

Cardiology requirements:

• Patients and their implanted systems must be screened to meet the following requirements:

– No previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors

– No broken leads or leads with intermittent electrical contact, as confirmed

by lead impedance history – A SureScan pacing system that has been implanted for a minimum of

6 weeks – A SureScan pacing system implanted in the left or right pectoral region – Pacing capture thresholds of ≤ 2.0 volts (V) at a pulse width of

0.4 milliseconds (ms) – A lead impedance value of ≥ 200 ohms (Ω) and ≤ 1,500 Ω – No diaphragmatic stimulation at a pacing output of 5.0 V, and at a pulse

width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan is on

Radiology requirements:

• Horizontal, cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used

• Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 Teslas per meter per second (T/m/s) must be used

• The scanner must be operated in Normal Operating mode:

– The whole-body–averaged specific absorption rate (SAR) must be ≤ 2.0 watts per kilogram (W/kg)

– The head SAR must be < 3.2 W/kg

• The patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra

• Proper patient monitoring must be provided during the MRI scan. The methods include visual and verbal contact with the patient, electrocardiography, and pulse oximetry (plethysmography).

Training requirements:

• A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan feature

• A health professional who has completed radiology SureScan training must be present during the MRI scan

Brief Statement

The Revo MRI™ SureScan® pacing system is MR Conditional and as such is designed to allow patients to undergo MRI under the specified conditions for use.

Indications

The Revo MRI SureScan Model RVDR01 IPG is indicated for use as a system consisting of Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI® SureScan 5086MRI leads. A complete system is required for use in the MRI environment.

The Revo MRI SureScan Model RVDR01 IPG is indicated for the following:

• Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity

• Accepted patient conditions warranting chronic cardiac pacing include:

– Symptomatic paroxysmal or permanent second- or third-degree AV block

– Symptomatic bilateral bundle branch block

– Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders

– Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias

The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include:

• Various degrees of AV block to maintain the atrial contribution to cardiac output

• VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm

Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.

Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications.

The device has been designed for the MRI environment when used with the specified MR Conditions of Use.

Contraindications

The device is contraindicated for:

• Implantation with unipolar pacing leads

• Concomitant implantation with another bradycardia device

• Concomitant implantation with an implantable cardioverter defibrillator

There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implantation procedure used by the physician.

• Rate responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate

• Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter

• Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance

• ATP therapy is contraindicated in patients with an accessory antegrade pathway

Warnings/Precautions

Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device should not change the application of established anticoagulation protocols.

Do not scan the following patients:

• Patients who do not have a complete SureScan pacing system, consisting of a SureScan device and two SureScan leads

• Patients who have previously implanted devices, or broken or intermittent leads

• Patients who have a lead impedance value of < 200 Ω or > 1,500 Ω

• Patients with a SureScan pacing system implanted in sites other than the left and right pectoral region

• Patients positioned such that the isocenter (center of MRI bore) is inferior to C1 vertebra and superior to the T12 vertebra

Brief Statement: Medtronic CareLink® Monitor/CareLink Network

Intended Use

The CareLink Monitor and the CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician.

Contraindications

There are no contraindications for the CareLink Monitor.

Potential Complications

Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.

Warnings and Precautions

The CareLink Monitor must only be used for interrogating compatible Medtronic implantable devices. The CareLink Monitor is intended for use within the prescribing country.

See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.

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