Healthcare Professionals
Evera MRI XT DR and VR
Implantable Cardioverter Defibrillators (ICDs)
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Healthcare Professionals
Implantable Cardioverter Defibrillators (ICDs)
Introducing MRI access. Medtronic’s first MR-conditional ICD.
Contoured. The PhysioCurve™ shape is designed with patient comfort in mind with a 30% reduction* in skin pressure.1
Long-lasting. Up to 25% greater longevity than our Protecta ICD,2† so patients spend more time living, and less time getting device replacements.
Smart. SmartShock™, the most advanced shock reduction suite. Enhanced, so patients receive fewer inappropriate shocks.3
Introducing MRI Access
It is estimated that up to 53 to 64% of ICD patients will have a medical need for an MRI within 10 years.1
Elderly patients are the primary users of MRI. Individuals over age 65 are twice as likely to need an MRI compared to younger patients.2
The potential need for an ICD also increases with age.
Medical and surgical specialties rely on MRI for diagnosis. In fact, MRI is the gold standard diagnostic tool for soft tissue imaging for neurologists, oncologists, and orthopedic surgeons. Your ICD choice today can affect their decisions and diagnostic capabilities tomorrow.
The Evera MRI ICD System with SureScan® technology has met the rigors of clinical evaluation, regulatory review, and FDA approval.
Multiple safety features were designed and incorporated from the ground up:
The two available SureScan lead options for SureScan ICDs include:
The SureScan pacing lead options for use with dual chamber SureScan ICDS include:
For additional information on SureScan Systems, please visit www.mrisurescan.com
Nazarian S, Reynolds M, Ryan M, et al. Estimating the Likelihood of MRI in Patients after ICD Implantation: A 10-Year Prediction Model. J Am Coll Cardiol.March 2015;65(10 Supp):A1090.
Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment – A Global Strategic Business Report. San Jose, CA. 2002.
Gillis AM, Pürerfellner H, Israel CW, et al. Reduction of unnecessary right ventricular pacing due to the managed ventricular pacing (MVP®) mode in patients with symptomatic bradycardia. Benefit for both sinus node disease and AV block indications. Heart Rhythm. 2005;Abstract AB21-1.
FEATURE | EVERA | EVERA MRI |
---|---|---|
SureScan™ Technology Full Body MRI |
✓ | |
SmartShock™ Six Medtronic exclusive algorithms, proven by the PainFREE SST Study. 98% of patients are free of inappropriate shocks at one year.1 |
✓ | ✓ |
PhysioCurve™ Designed for patient comfort. 30% less skin pressure versus conventional ICD shapes.2 |
✓ | ✓ |
CareLink® Network Remote monitoring capability for all cardiac devices |
✓ | ✓ |
Longevity | 25% greater than Protecta 10 year extended warranty (XT) |
Same as Evera |
OptiVol® Fluid Status Monitoring |
XT Only | XT Only |
FEATURE | EVERA | EVERA MRI |
---|---|---|
SureScan™ Technology Full Body MRI |
✓ | |
SmartShock™ Six Medtronic exclusive algorithms, proven by the PainFREE SST Study. 98% of patients are free of inappropriate shocks at one year.1 |
✓ | ✓ |
PhysioCurve™ Designed for patient comfort. 30% less skin pressure versus conventional ICD shapes.2 |
✓ | ✓ |
AF Diagnostics* | ✓ | ✓ |
CareLink® Network Remote monitoring capability for all cardiac devices |
✓ | ✓ |
Longevity | 25% greater than Protecta 8 year warranty (XT) |
Same as Evera 8 year warranty (XT) |
OptiVol® Fluid Status Monitoring |
XT Only | XT Only |
Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm. May 2015;12(5):926-936.
Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
SureScan Leads
SURESCAN LEADS | 6947M | 6935M |
---|---|---|
Type | Dual coil, quadripolar | Single coil, tripolar |
Fixation | Helix, active fixation | Helix, active fixation |
Inner/Outer Insulator | Silicone, PTFE, ETFE | Silicone, PTFE, ETFE |
Body | 8.6 Fr (2.8 mm) | 8.6 Fr (2.8 mm) |
Recommended Introducer Size | Without guide wire 9.0 Fr (3.0 mm) With guide wire 11.0 Fr (3.7 mm) |
Without guide wire 9.0 Fr (3.0 mm) With guide wire 11.0 Fr (3.7 mm) |
Spacing | 8 mm tip-ring 12 mm tip-distal RV coil 180 mm tip-SVC electrode |
8 mm tip-ring 12 mm tip-distal RV coil |
MR Conditional Lengths | 55, 62 cm | 55, 62 cm |
Approved MR Conditional Devices | Evera MRI™ XT DR DDMB1D4 Evera MRI S DR DDMC3D4 Evera MRI XT VR DVMB1D4 |
Evera MRI™ XT DR DDMB1D4 Evera MRI S DR DDMC3D4 Evera MRI XT VR DVMB1D4 |
Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
Evera DR/VR ICD Manuals.
Medtronic data on file. November 15, 2012.
Analysis was done on DR devices.
Projected service life estimates are based on accelerated battery discharge data and device modeling as specified. Do not interpret these values as precise numbers.
IMPORTANT INFORMATION ON INDICATIONS, SAFETY AND WARNINGS
For listing of Indications, Contraindications, Warnings, Precautions, and Potential Adverse Events, please refer to the Instructions For Use .