Jul 5, 2017

Medtronic Receives Health Canada Licence for New Single-Chamber ICDS that Detect Atrial Fibrillation

Brampton, Canada - July 05, 2017 - Medtronic plc (NYSE: MDT) today announced it has received a Health Canada licence for the Visia AF MRI SureScan and Visia AF single-chamber implantable...

Visia AF MRI™ SureScan™ and Visia AF™ ICDs Treat Dangerous Heart Rhythms and Enable Physicians to Identify Patients at Increased Risk for Stroke and Heart Failure Due to AF

Brampton, Canada - July 05, 2017 -

Medtronic plc (NYSE: MDT) today announced it has received a Health Canada licence for the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators (ICDs). The Visia AF devices can detect previously undiagnosed and/or asymptomatic atrial fibrillation (AF) and monitor recurrent AF, while treating life-threatening rhythms in the lower chambers of the heart. The Visia AF ICD systems are now commercially available in Canada.

AF is a condition that involves an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart. Because many patients do not experience symptoms, the condition frequently goes undetected, even with traditional external monitors1-2. When left untreated, patients with AF are five times more likely to have a stroke3 and three times more likely to develop heart failure4.

The Visia AF ICDs include a proprietary algorithm that detects AF episodes (without a lead in the atrium) and captures AF frequency and duration, information that helps physicians identify AF and tailor treatment for these patients.

Built on the proven performance of the Medtronic Evera™ family of ICDs, the Visia AF ICDs include:

  • SureScan™ Labeling: Approved for MRI scans on any part of the body without positioning restrictions, as well as for MRI scans in 1.5 Tesla (magnet strength) machines
  •  Physio Curve™ Design: A contoured shape with thin, smooth edges that increases patient comfort by reducing skin pressure by 30 percent5
  • Greater Battery Longevity: Industry-leading battery longevity (up to 11 years)6-13
  • Sprint Quattro™ Leads: Paired with the Sprint Quattro™ family of leads, the most frequently prescribed lead, with more than 10 years of proven performance with active monitoring14
  • SmartShock™ 2.0: An exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms,15 delivering a 98 percent inappropriate shock-free rate at one year16

In addition, remote monitoring through the Medtronic CareLink™ Network is available with the Visia AF ICDs, connecting patients to their clinics from home or away.

"Early detection of AF is vital to assist physicians in making treatment decisions that can reduce stroke and heart failure risk,” said Michael Blackwell, senior director, Cardiac and Vascular Group at Medtronic Canada. “These single chamber defibrillators with AF detection capabilities, utilizing our proven Quattro lead – alongside our overall portfolio of AF detection devices – demonstrate our commitment to providing cardiac patients with the latest technology to improve their health.”

The Visia AF ICDs received CE Mark in 2015, and U.S. FDA approval in 2016. The Health Canada licence further expands the Medtronic portfolio of MR-conditional cardiac rhythm and heart failure devices, which includes MR-conditional pacemakers, ICDs, insertable cardiac monitors (ICMs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers one of the broadest ranges of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic

Medtronic Canada (www.medtronic.ca), headquartered in Brampton, Ontario is a subsidiary of Medtronic plc, which is one of the world’s largest medical technology, services and solutions companies — alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.


Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.




Strickberger SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. 2005;2:125-31.


Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006;3:1445-52.


Wolff PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke the Framingham Study. Stroke. 1991;22 (8): 983-988.


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/Paisey Study. Am J Med. October 1, 2002; 113 (5):359-364.


Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.


Knops P, Theuns DA, Res JC, et al. Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection. Pacing Clin Electrophysiol. October 2009;32(10):1276-1285.


Schaer BA, Koller MT, Sticherling C, et al. Longevity of implantable cardioverter defibrillators, influencing factors, and comparison to industry-projected longevity. Heart Rhythm. December 2009;6(12):1737-1743.


Biffi M, Ziacchi M, Bertini M, et al. Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems. Europace. November 2008;10(12):1288-1295.


Kallinen L, et al. 2009. http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913.


Thijssen J, Borleffs CJ, van Rees JB, et al. Implantable cardioverter-defibrillator longevity under clinical circumstances: an analysis according to device type, generation, and manufacturer. Heart Rhythm. April 2012;9(4):513-519.


Shafat T, Baumfeld Y, Novack V, et al. Significant differences in the expected versus observed longevity of implantable cardioverter defibrillators (ICDs). Clin Res Cardiol. Published online July 14, 2012.


Horlbeck FW, Mellert F, Kreuz J, et al. Real-world data on the lifespan of implantable cardioverterdefibrillators depending on manufacturers and the amount of ventricular pacing. J Cardiovasc Electrophysiol.December 2012;23(12):1336-1342.


Visia AF/Visia AF MRI Manuals.


Medtronic Product Performance Report, 2012 Second Edition, Issue 66.


Volosin KJ, Exner DV, Wathen MS, et al, Combining shock reduction strategies to enhance ICD therapy: arole for computer modeling. J Cardiovasc Electrophysiol. 2011 Mar;22(3):280-9.


Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients with single and dual/triple chamber ICDs using a novel suite of detection algorithms: PainFree SST Trial Primary Results. Heart Rhythm. 2015 May;12(5):926-36.


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