EU gives CE mark approval to Visia AF single-chamber implantable cardioverter defibrillators for atrial fibrillation- Medtronic

Medtronic has received CE Mark approval 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). In the US, the Visia AF ICDs are not yet approved for commercial use.

The Visia AF devices include a proprietary algorithm that accurately detects AF episodes, captures AF burden frequency and duration, and alerts the physician from the patient's home. They also feature a contoured shape with thin, smooth edges that reduces skin pressure by 30%, plus SmartShock 2.0, a shock reduction algorithm that enables the device to 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% of patients with implantable defibrillators may experience inappropriate shocks. SmartShock technology helps reduce these inappropriate shocks, and delivers a 98% inappropriate-shock-free rate at one year.