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Visia AF MRI™ SureScan™ and Visia AF™ ICDs
The Medtronic Visia AF MRI™ SureScan™ and Visia AF™ implantable
cardioverter defibrillators (ICDs) are single-chamber ICDs that can detect
atrial fibrillation (AF), while also treating life threatening rhythms in the
lower chambers of the heart. The Visia AF ICDs include a proprietary
algorithm that accurately detects AF episodes, captures AF burden
frequency and duration1, and alerts the physician from the patient’s home,
enabling physicians to manage patients at increased risk for stroke and
heart failure.
The ability to detect and monitor new onset, asymptomatic, and previously undiagnosed AF
has not been possible in traditional single-chamber ICDs until now. When paired with the
Sprint Quattro Secure MRI™ SureScan™ DF4 leads, the Visia AF MRI SureScan device also allows
patients to undergo full-body MRI scans.
The Visia AF MRI SureScan and Visia AF ICDs received FDA approval in 2016 and CE Mark in
2015.
Specific Device Features
 Paired with Sprint Quattro® Leads: The system utilizes the industry standard Sprint
Quattro® single and dual coil leads, with more than 11 years of proven performance with
active monitoring2. The Sprint Quattro Secure MRI™ SureScan™ DF4 leads have been
demonstrated safe for use in an MRI environment3.
 SmartShock™ 2.0 Technology: Exclusive, industry-leading shock reduction algorithm that
enables the devices to better differentiate between dangerous and harmless heart
rhythms4.
 PhysioCurve® Design: A contoured shape with thin, smooth edges that increases patient
comfort by reducing skin pressure by 30 percent5.
 Industry-Leading Projected Longevity6 and Warranty7: Battery longevity of 11 years, and
a 10-year warranty.
Importance of Atrial Fibrillation Detection
 An estimated 3 million people in the United States have AF8.
 AF is a condition that involves an irregular quivering or rapid heart rhythm in the upper
chambers (atria) of the heart, and patients with AF are five times more likely to have a
stroke9 and three times more likely to have heart failure10.
 Approximately 20 percent of patients with single chamber ICDs who experience
ventricular arrhythmias (irregular heart rhythms in the lower chambers) may develop AF in
the first two years after their device implant11, which often goes undetected with
traditional external monitors12-13.
 Early detection of AF can help physicians better tailor treatment to the needs of the
patient.
1
Medtronic data on file.
Medtronic Product Performance Report, 2012 Second Edition, Issue 66.
Models 6935M (55cm, 62cm) and 6947M (55cm, 62cm).
4
Volosin KJ, Exner DV, Wathen MS, et al, Combining shock reduction strategies to enhance ICD therapy: a role for computer
modeling. J Cardiovasc Electrophysiol. 2011 Mar;22(3):280-9.
5
Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
6
http://manuals.medtronic.com/manuals/mri/region.
7
Limited lifetime warranty, some restrictions may apply. The limited lifetime warranty applies to the performance of the device
and includes some reimbursement to patients of unreimbursed medical expenses. The warranty is limited to the provisions in the
2
3
written Limited Warranty document that accompanies each product. Consult the written limited warranty document for details,
a copy of which will be provided upon request.
8
Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J
Cardiol. December 2009;104(11):1534-1539.
9
Wolff PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke the Framingham Study. Stroke.
1991;22 (8): 983-988.
10
Stewart S, Hart CL, Hole DJ, et al. A population-based study of the long-term risks associated with atrial fibrillation: 20-year
follow-up of the Renfrew/ Paisley Study. Am J Med. October 1, 2002;113(5):359-364.
11
Medtronic data on file.
12
Strickberger SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. 2005;2:12531.
13
Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm.
2006;3:1445-52.