Revo MRI
Pacing System
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Revo MRI SureScan Pacing System

Now your patients can get proven cardiac pacing care with MRI access. Revo MRI is specifically engineered for MRI safety – the first MRI pacing system FDA-approved for use with MRI.

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

Meeting the Need for Safe Pacing and MRI

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Detail - Average Age of Pacemaker Patient

It is estimated that up to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device.1

Convergence of Needs: MRI and Pacemakers

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 a pacemaker also increases with age.

Comprehensive Patient Care

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Detail - Prevalence of Common Comorbidities

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 orthopaedic surgeons. Your pacemaker choice today can affect their decisions and diagnostic capabilities tomorrow.

The prevalence of common comorbidities increases over age 65,3-5 often requiring MRI – the same population most likely to require a pacemaker.

How the  Revo MRI Pacing System Works

Radiopaque icons confirm SureScan technology 
Detail - The 5086 lead's easily identifiable radiopaque icons confirm SureScan technology. The 5076 lead does not have a radiopaque marker.

The  Revo MRI Pacing System with SureScan® technology has met the rigors of clinical evaluation, regulatory review, and FDA approval.

The Revo MRI Pacemaker Was Specifically Engineered for the MRI Environment

Multiple safety features were designed and incorporated from the ground up:

  • Device verification appears on pacemaker programmer screen
  • One-screen programming clearly outlines necessary steps to scanning and pacing
  • The Revo MRI pacemaker contains an easily identifiable radiopaque marker. The SureScan leads may or may not contain the radiopaque marker.
  • Device contains robust circuitry
  • Dedicated programming mode provides additional security and backup for “Power On Reset” (POR)
  • Hall sensor immune to strong magnetic fields

Two SureScan Lead Options That Are Proven Safe and Effective in the MRI Environment

The two available SureScan lead options:

  • CapSureFix Novus MRI SureScan Model 5076
  • CapSureFix MRI SureScan Model 5086

Over 3.2 M 5076 leads have been sold worldwide with over 97.6% reliability at 10 years.6

MVP® Mode promotes intrinsic conduction with backup pacing

Managed Ventricular Pacing Mode

Builds Upon Medtronic Innovations

  • Managed Ventricular Pacing (MVP®) promotes intrinsic conduction and reduces unnecessary right ventricular pacing by 99%7
  • Cardiac Compass® graphically displays more than a year of trended data to help monitor and manage AF and AT

For additional information on SureScan Pacing Systems, please visit www.mrisurescan.com

 

References

  1. Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):326-328.
  2. Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment – A Global Strategic Business Report. San Jose, CA. 2002.
  3. 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.
  4. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. May 1998;41(5):778-799.
  5. American Heart Association. Heart Disease and Stroke Statistics – 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: 2003-2006).
  6. DeBus, Becky.  Model 5076 Lead Survival Function Calculation. August 2014. Medtronic Data On File.
  7. Gillis AM, Pürerfellner H, Israel CW, et al. Reduction of unnecessary ventricular pacing due to the Managed Ventricular Pacing (MVP) mode in pacemaker patients: benefit for both sinus node disease and AV block indications. Heart Rhythm. 2005;Abstract B21-1.

MINERVA Results Summary1

Evaluated whether DDDRP + MVP® reduces mortality, morbidity, or permanent AF compared with standard dual chamber pacing.

Multicenter (63 centers) international, randomized single blind study with 3 arms enrolling 1,166 patients with:

  • Class I or Class II indications for dual chamber pacing
  • Previous atrial tachyarrhythmias
  • No history of permanent AF or third-degree AV block

MINERVA image

49% relative reduction (p = 0.001) in cardioversions
for atrial arrhythmias between DDDRP + MVP and
Control DDDR

52% relative reduction (p < 0.0001) in AF-related
hospitalizations and ER visits between DDDRP + MVP
and Control DDDR

Potential Contribution of Reactive ATP®
Risk of AF > 7 days and aATP efficacy

MINERVA image 2

  • When aATP is successful, significantly fewer patients have AF episodes > 7 days
  • Reactive ATP is a key contributor to these results

References

  1. Boriani G, et al. Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial. Eur Heart J. Published online April 25, 2014.

Specifications

Revo MRI SureScan Pacemaker
Size 12.7 cc
Weight 21.5 g
SureScan Leads 5076 5086
Polarity Bipolar Bipolar
Shape Straight Straight
Fixation Screw-in Screw-in
Inner/Outer Insulator Silicone Silicone
Body 6.1 Fr 7 Fr
Recommended Introducer Size 9 Fr with guidewire
7 Fr without guidewire
11 Fr with guidewire
8 Fr without guidewire
Tip-to-Ring Spacing 10mm 10mm
Standard Lengths 35, 45, 52, 58, 65, 85 cm 45, 52, 58 cm
Last updated: 20 Oct 2014

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