US FDA grants Medtronic approval for Visia single-chamber implantable cardioverter defibrillators



Medtronic has announced it has received US Food and Drug Administration (FDA) approval for the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators (ICDs).

The Visia AF devices are designed to detect previously undiagnosed and/or asymptomatic atrial fibrillation and monitor recurrent atrial fibrillation, while treating life-threatening rhythms in the lower chambers of the heart. The Visia AF ICD systems will be commercially available in early summer.

The Visia AF ICDs include a proprietary algorithm intended to detect atrial fibrillation episodes (without a lead in the atrium) and capture atrial fibrillation frequency and duration

“Approximately 75% of ICD patients have no history of atrial fibrillation at the time they receive a device,” says Edward J Schloss, director of cardiac electrophysiology, The Christ Hospital, Cincinnati, USA. “After device implant, we have seen about 20% of these patients go on to have newly discovered atrial fibrillation. Until now, we have not been able to detect these arrhythmias with single chamber ICD diagnostics. The Visia AF ICDs give physicians a new tool to monitor for atrial fibrillation in patients with VR ICDs, which may allow them to identify and treat atrial fibrillation earlier to potentially help avoid other serious conditions.”

Built on the Evera family of ICDs, the Visia AF ICDs include:

  • SureScan labelling: 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 should increase patient comfort by reducing skin pressure by 30%.
  • Greater battery longevity: Industry-leading battery longevity (up to 11 years)
  • Sprint Quattro leads
  • SmartShock 2.0: A shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms, delivering a 98% inappropriate shock-free rate at one year.

In addition, remote monitoring through the Medtronic CareLink Network is available with the Visia AF ICDs, connecting patients to their clinics.