Medtronic’s Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators (ICD) for atrial fibrillation have received FDA approval.

Built into the ICD is an algorithm, SmartShock 2.0, that can differentiate between dangerous and harmless heart rhythms and delivers a 98 percent inappropriate shock-free rate. Additionally, the algorithm can detect undiagnosed, asymptomatic AF and monitor recurrent AF while treating life-threatening rhythms.

Visia ICDs have a battery life of up to 11 years and include SureScan Labeling, which has been approved for MR scans on any part of the body, and remote monitoring through the Medtronic CareLink Network can connect patients to their clinics.
The MRI SureScan allows patients to undergo full-body MRI scans in 1.5 Tesla scanners, which may be beneficial for patients since the number of MR scans performed increases each year, as does the number of people with ICDs, Tracy McNulty, a Medtronic spokesperson, told HCB News, and more than one-third of patients who receive an ICD are likely to need an MR within four years.

“Approximately 75 percent of ICD patients have no history of atrial fibrillation at the time they receive a device,” said Dr. Edward J. Schloss, director of cardiac electrophysiology at The Christ Hospital, in a statement.

Unlike dual chamber ICDs that have leads placed in both the right atrium and right ventricle, the ability to detect and monitor for AF has not been possible in traditional single-chamber ICDs without a lead in the atrium, making the Visia ICD the first device to do so.

“After device implant, we’ve seen about 20 percent of these patients go on to have newly discovered AF, [and] until now, we haven’t been able to detect these arrhythmias with single chamber ICD diagnostics,” Schloss said.

Many patients do not experience symptoms, so the condition frequently goes undetected, even with traditional external monitors, according to the announcement, and when left untreated, patients with AF are five times more likely to have a stroke and three times more likely to develop heart failure.

The Visia ICDs received CE mark in October 2015.

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