Medtronic receives CE mark for new single-chamber ICDs designed to detect atrial fibrillation


Medtronic has received CE mark for its single-chamber implantable cardioverter defibrillators (ICDs), Visia AF and Visia AF MRI SureScan. The products are designed to detect and monitor new onset, asymptomatic and previously undiagnosed atrial fibrillation (AF).

The Visia AF devices include an algorithm designed to accurately detect AF episodes, capture AF burden frequency and duration, and alert the physician from the patient’s home.

The Visia AF ICDs also feature a contoured shape with thin, smooth edges which, Medtronic claims, can increase patient comfort by reducing skin pressure by 30%. The devices include the same industry-leading battery longevity (up to 11 years) compared to previous devices.

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, according to Medtronic. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20% 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% inappropriate shock-free rate at one year.

In the USA, the Visia AF ICDs are not yet approved for commercial use.