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.
Additionally, the Revo MRI SureScan pacing system has been proven to reduce the progression to permanent AF, as seen in the MINERVA study.*
Meeting the Need for Safe Pacing and 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.
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
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.
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
Atrial ATP quickly delivers painless therapies to restore sinus rhythm7,8
How the Revo MRI Pacing System Works
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% reliability9
- Designed and engineered for safety in the MRI environment
- Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):326-328.
- Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment – A Global Strategic Business Report. San Jose, CA. 2002.
- 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.
- 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.
- American Heart Association. Heart Disease and Stroke Statistics – 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: 2003-2006).
- 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.
- 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.
- 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.
- Medtronic Product Performance Report, 2010 Second Edition, Issue 63.
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
49% relative reduction (p = 0.001) in cardioversions
for atrial arrhythmias between DDDRP + MVP and
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
- When aATP is successful, significantly fewer patients have AF episodes > 7 days
- Reactive ATP is a key contributor to these results
- 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.
|Revo MRI SureScan Pacemaker|
|CapSureFix MRI Model 5086|
|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|