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 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.

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.

Revo MRI Pacing System – FDA-Approved for MRI Use

Now for the first time, Revo MRI allows you to implant leading-edge pacing innovation with access to today’s gold standard diagnostic tool.

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%6
  • Cardiac Compass® graphically displays more than a year of trended data to help monitor and manage AF and AT
  • Reactive ATP (Antitachycardia Pacing) continuously monitors and responds to changes in rate or regularity of AT episodes, and appropriately delivers atrial ATP therapies to restore sinus rhythm
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Atrial ATP quickly delivers painless therapies to restore sinus rhythm7,8

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. 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.
  7. Lee M, Weachter R, Pollack S, et al. The effect of atrial pacing therapies on atrial tachyarrhythmia burden and frequency. J Am Coll Cardiol. 2003;41:1926-1932.
  8. Israel C. Success rate of automatic atrial antitachycardia pacing by a pacemaker implanted in patients with paroxysmal and persistent atrial tachyarrhythmia. Circulation. 2000;102(Supp II, No. 18). Abstract 3454.

How the Revo MRI Pacing System Works

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Detail - Easily identifiable radiopaque icons confirm SureScan technology

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

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
  • Easily identifiable SureScan radiopaque icon on the device and lead confirms SureScan technology
  • Device contains robust circuitry
  • Dedicated programming mode provides additional security and backup for “Power On Reset” (POR)
  • Hall sensor immune to strong magnetic fields

A Lead Designed for Use in the MRI Environment

The CapSureFix MRI® SureScan Lead Model 5086:

  • Based on the CapSure® family of leads – more than 2 million leads implanted, with 99.5% reliability1
  • Designed and engineered for safety in the MRI environment

Reference

  1. Medtronic Product Performance Report, 2010 Second Edition, Issue 63.

Specifications

Revo MRI SureScan Pacemaker
Size 12.7 cc
Weight 21.5 g
CapSureFix MRI Model 5086
Polarity Bipolar
Shape Straight
Fixation Screw-in
Inner/Outer Insulator Silicone
Body 7 Fr
Recommended Introducer Size 8 Fr (without guide wire)
Tip-to-Ring Spacing 11 Fr (with guide wire)
Standard Lengths 45 cm, 52 cm, 58 cm
Last updated: 8 Feb 2011

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