Pacemaker Overview

Advisa MRI SureScan Pacing System

Now two generations ahead in pacemakers approved for MRI

  • Most advanced pacing technology
  • Only pacing technology FDA approved for full body MRI scans
  • Designed and tested for cardiac MRI1
  • Proven reduction of progression to permanent AF2

The Advisa 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 Advisa 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

crdm-3aThe Advisa 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 Advisa MRI SureScan IPG implanted with two CapSureFix MRI™ SureScan leads is required for use in the MRI environment.

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.3

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.4

The potential need for a pacemaker also increases with age.

Comprehensive Patient Care

Detail – Prevalence of Common Comorbidities

crdm-5Medical 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 capabilitiestomorrow.

The prevalence of common comorbidities increases over age 65,5-7 often requiring MRI – the same population most likely to require a pacemaker.

Advisa MRI Pacing System – FDA-Approved for MRI Use

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

Builds Upon Medtronic Innovations

  • Managed Ventricular Pacing (MVP®) promotes intrinsic conduction and reduces unnecessary right ventricular pacing by 99%8
  • 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

Atrial ATP quickly delivers painless therapies to restore sinus rhythm9,10

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

How the Advisa MRI Pacing System Works

Detail – Easily identifiable radiopaque icons confirm SureScan technology

surescan_technology_image_lgThe Advisa 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% reliability11
  • Designed and engineered for safety in the MRI environment

References

  1. Schwitter J, Kanal E, Schmitt M, et al. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of caridac muscle during scans: Advisa randomized clinical multicenter study results. Heart Rhythm. June 2013;10(6):864-872.
  2. 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.
  3. Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):326-328.
  4. Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment – A Global Strategic Business Report. San Jose, CA. 2002.
  5. 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.
  6. 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.
  7. American Heart Association. Heart Disease and Stroke Statistics – 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: 2003-2006).
  8. 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.
  9. 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.
  10. 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.
  11. Medtronic Product Performance Report, 2010 Second Edition, Issue 63.