Medtronic receives CE Mark for New Single-Chamber ICDs

The new single-chamber implantable cardioverter defibrillators (ICDs) can detect atrial fibrillation


The Visia AF devices include a proprietary algorithm that accurately detects AF episodes

Medtronic has announced it has received CE (Conformité Européenne) Mark for the Visia AF and Visia AF MRI SureScan single-chamber implantable cardioverter defibrillators (ICDs), which can detect and monitor new onset, asymptomatic, and previously undiagnosed atrial fibrillation (AF). The Visia AF devices include a proprietary algorithm that accurately detects AF episodes, captures AF burden frequency and duration1, and alerts the physician from the patient's home.

Built on the proven performance of the Medtronic Evera family of ICDs, the Visia AF ICDs also feature a contoured shape with thin, smooth edges that increases patient comfort by reducing skin pressure by 30 percent. The devices include the same industry-leading battery longevity (up to 11 years) compared to previous devices. And when paired with the Sprint Quattro Secure MRI SureScan DF4 leads - part of the only ICD lead family with more than 10 years of proven performance with active monitoring - the Visia AF MRI SureScan device allows patients to undergo full-body MRI scans.

The Visia AF ICDs include SmartShock 2.0, an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20 percent of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. SmartShock technology helps to eliminate these inappropriate shocks, and delivers a 98 percent inappropriate shock-free rate at one year.

"Medtronic is committed to continuing to develop a wide range of technologies to help patients with AF. With devices like the Visia AF ICDs and the Reveal LINQ Insertable Cardiac Monitor, which detects and monitors abnormal heart rhythms for up to three years, we aim to increase AF detection and enable physicians to manage a patient's risk for strokes and heart failure," said Dr Marshall Stanton, vice-president and general manager of the Tachycardia business, which is part of the Cardiac Rhythm and Heart Failure division at Medtronic.



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