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FDA approved for MRI use

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FDA approved for MRI use The first pacing system to break the image barrier The Revo MRI SureScan pacing system is MR Conditional designed to allow patients to ... – PowerPoint PPT presentation

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Title: FDA approved for MRI use


1
FDA approved for MRI use The 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.
2
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.

3
Meeting the Need for MRI
  • Pacemaker Implants in an Aging Population
  • The number of pacemakers currently implanted in
    the United States is approximately 1.5 million1,2

Average Age of Pacemaker Patient
13 Ages 25-64
86 Age 65
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
1 Kalin R, Stanton MS. PACE. 200528326-328. 2
Zhan C, et al. Gen Intern Med. 20082313-19. 3
Global Industry Analysts, Inc. Magnetic Resonance
Imaging (MRI) Equipment a global strategic
business report. San Jose, CA. 2002.
4
Part of Comprehensive Patient Care
  • Medical and Surgical Specialties Rely on
  • MRI for Diagnosis
  • Your choice can affect their decisions and
    diagnostic capabilities
  • 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

15 0 comorbidities
Opthalmology
Neurosurgery
30 1 comorbidity
851 1 or more comorbidities
Otolaryngology
Neurology
27 3 or more comorbidities
Oncology
Cardiothoracic Surgery
28 2 comorbidities
Radiation Oncology
Surgical Oncology
Interventional Radiology
Nephrology
Gynecologic Oncology
Gastrointestinal Surgery
Urology
  • Given that 85 of all pacemaker patients have one
    or more comorbidities, facilitating comprehensive
    multispecialty care is important in todays
    environment

Orthopedic Surgery
Rheumatology
Vascular Surgery
1 Kalin R, Stanton MS. PACE. 200528326-328.
5
Prevalence of Common Comorbiditiesin the
Pacemaker Patient Population
  • The Prevalence of Common Comorbidities Increases
    Rapidly Over Age 65.1-3
  • MRI Is the Gold Standard Diagnostic Tool for
  • Neurologists, 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 Are
  • Musculoskeletal and Neurological Symptoms.6
  • Medicare records show that in patients gt 65 years
    of age with
  • an 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.
199841778-799. 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. 200528326-328. 6 Medical
Imaging Survey, 2009. 7 Medicare Fee-for-Service
Review, 2007.
6
Hazards and Risks of MRI with Current Pacing
Systems
  • Since 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
  • 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 Medtronics website
    at www.medtronic.com or call Medtronic at 1
    (800) 328-2518.

11 Calcagnini G, et al. J Magn Reson Imaging.
200828879-886. 12 Dyrda K, Khairy P. Expert
Rev Cardiovasc Ther. 20086823-832. 13 Gimbel
JR. Pacing Clin Electrophysiol. 200831795-801.
14 Nordbeck P, Bauer WR. Dtsch Med Wochenschr.
2008133624-628.Article in German. 15 Tandri
H, et al. Heart Rhythm. 20085462-468.
16 Roguin A, et al. Circulation.
2004110475-482. 17 Medtronic, Inc. EnRyhthm
MRI SureScan Pacing System Clinical Report, in
support of FDA premarket approval.
1 Naehle CP, et al. Pacing Clin Electrophysiol.
2009321526-1535. 2 Goldsher D, et al. Pacing
Clin Electrophysiol. 2009321355-1356. 3 Gimbel
JR. Europace. 2009111241-1242. 4 Naehle CP, et
al. J Am Coll Cardiol. 200954549-555. 5 Roguin
A. J Am Coll Cardiol. 200954556-557.
6 Mollerus M, et al. Pacing Clin Electrophysiol.
2008311241-1245. 7 Pulver AF, et al. Pacing
Clin Electrophysiol. 200932450-456. 8 Nordbeck
P, et al. Magn Reson Med. 200961570-578.
9 Sutton R, et al. Trials. 2008968. 10 Naehle
CP, et al. Radiology. 2008249991-1001.
7
Specifically Engineered for MRI Safety
  • Device 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

8
Specifically Engineered for MRI Safety
  • Lead Heating Design Solution
  • Lead inner conductor coil design mitigates lead
    heating
  • 4 filar to 2 filar increases inductance and
    reduces heating

Easily Identifiable, Radiopaque Icon Confirms
SureScan Device Implant Lead HeatingModel
5076 versus Model 5086 MRI
  • 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 thats 2.5 million
    leads, with 99.5 reliability
  • 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

9
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.
10
  • 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

11
Clinical Trial Demonstrates the Safetyof Revo
MRI SureScan1
  • 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

1 Medtronic, Inc. EnRyhthm MRI SureScan Pacing
System Clinical Report, in support of FDA
premarket approval.
12
Clinical Trial Demonstrates the Safetyof Revo
MRI SureScan1
  • Key Results
  • 100 were free of MRI-related complications (n
    211, P lt 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.
13
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 991
  • 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.
200851e1-62. 3 Sweeney MO, et al. Circulation.
2003102932-2937. 4 Nielsen JC, et al. J Am Coll
Cardiol. 200342614-623. 5 Gardiwal A, et al.
Europace. 200810358-363. 6 Medtronic CareLink
Metrics Database.
14
  • Revo MRI Pacing System Conditions for Use
  • A complete SureScan pacing system including a
    Revo MRI SureScan
  • IPG 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 MRI
  • scan. The SureScan feature must be programmed to
    On prior to scanning a
  • patient 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 (?)
    and 1,500 ?
  • 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-bodyaveraged specific absorption
    rate (SAR) must be 2.0 watts per kilogram
    (W/kg)
  • The head SAR must be lt 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

15
  • 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

16
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 The
re 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 Medtronics
website at www.medtronic.com. Caution Federal
law (USA) restricts these devices to sale by or
on the order of a physician.
  • There are no known contraindications for the use
    of pacing as a therapeutic modality to control
    heart rate. The patients 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 patients disease and/or medications
    may alter the efficacy of the devices 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 lt
    200 O or gt 1,500 O
  • 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
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