Download FDA approved for MRI use

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.
The First and Only Pacing System
FDA 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 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. 2005;28:326-328.
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.
2
Part of Comprehensive Patient Care
• Now, for the first time, you can implant a state-ofthe-art pacing system to provide proven cardiac
care AND MRI access when your patients need it
Medical and Surgical Specialties Rely on
MRI for Diagnosis
Number of Comorbidities in Pacemaker Patients
• Your choice can affect their decisions and diagnostic capabilities
15%
0 comorbidities
Opthalmology
Neurosurgery
30%
1 comorbidity
27%
85%1
1 or more
comorbidities
3 or more
comorbidities
Otolaryngology
Cardiothoracic Surgery
28%
2 comorbidities
Surgical Oncology
Nephrology
Gynecologic Oncology
• Given that 85% of all pacemaker patients have one or
more comorbidities, facilitating comprehensive
multispecialty care is important in today’s environment
1
Kalin R, Stanton MS. PACE. 2005;28:326-328.
Urology
Rheumatology
Neurology
Oncology
Radiation Oncology
Interventional Radiology
Gastrointestinal Surgery
Orthopedic Surgery
Vascular Surgery
Prevalence of Common Comorbidities
in 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 > 65 years of age with
an implanted pacemaker:
• 34% have spine and intervertebral
disc disease7
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.
• 36% have chronic pain of wrist, foot, ankle,
or elbow7
• 14% suffer from injury or trauma to the spine, knee,
or shoulder7
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:
Field
Impact
Lead Heating
The 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 Stimulation
The 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 Interactions
The 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.
Static
Gradient
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.
1
2
3
4
5
6
7
8
9
10
Naehle CP, et al. Pacing Clin Electrophysiol. 2009;32:1526-1535.
Goldsher D, et al. Pacing Clin Electrophysiol. 2009;32:1355-1356.
Gimbel JR. Europace. 2009;11:1241-1242.
Naehle CP, et al. J Am Coll Cardiol. 2009;54:549-555.
Roguin A. J Am Coll Cardiol. 2009;54:556-557.
Mollerus M, et al. Pacing Clin Electrophysiol. 2008;31:1241-1245.
Pulver AF, et al. Pacing Clin Electrophysiol. 2009;32:450-456.
Nordbeck P, et al. Magn Reson Med. 2009;61:570-578.
Sutton R, et al. Trials. 2008;9:68.
Naehle CP, et al. Radiology. 2008;249:991-1001.
11
12
13
14
15
16
17
Calcagnini G, et al. J Magn Reson Imaging. 2008;28:879-886.
Dyrda K, Khairy P. Expert Rev Cardiovasc Ther. 2008;6:823-832.
Gimbel JR. Pacing Clin Electrophysiol. 2008;31:795-801.
Nordbeck P, Bauer WR. Dtsch Med Wochenschr. 2008;133:624-628.[Article in German.]
Tandri H, et al. Heart Rhythm. 2008;5:462-468.
Roguin A, et al. Circulation. 2004;110:475-482.
Medtronic, Inc. EnRyhthm MRI SureScan Pacing System
Clinical Report, in support of FDA premarket approval.
RF
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
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
• Materials identical to 5076*
• Model 5086MRI lead flex testing
– Connector/body
– Lead body
• Model 5086MRI clinical implant
experience starting February 2007
(928 leads implanted)
Easily Identifiable, Radiopaque Icon Confirms
SureScan Device Implant
Lead Heating
Model 5076 versus Model 5086 MRI
*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
– 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 Library
Lead Paths
• 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
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
Clinical Trial Demonstrates the Safety
of Revo MRI™ SureScan®1
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.
Clinical Trial Demonstrates the Safety
of 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
Medtronic CareLink® Network*
• Exclusive technology that uses atrial pacing (AAIR) primarily, with DDD(R)
pacing only when necessary
• The leading Internet-based, remote monitoring service
for implanted devices6
• Serving nearly 500,000 patients in 3,000 clinics in the
United States
• 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.
1
Gillis AM, et al. Heart Rhythm. 2005. Abstract AB21-1.
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.
2
* Not all devices are available on the CareLink® Network
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 (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.