FDA approves Visia implantable cardioverter defibrillators for atrial fibrillation- Medtronic

Medtronic has received FDA approval 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 will be commercially available in early summer.

Comment: 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. More than half of all new ICD implants in the U.S. are single-chamber devices. The Visia AF ICDs received CE Mark in 2015.