Brampton, Canada - July 5, 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.
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.