FDA approves ICDs for atrial fibrillation

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The FDA approved the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators (ICDs) on May 2 to treat patients with atrial fibrillation.

Medtronic said the ICD systems would be available in early summer.

The devices are intended to detect previously undiagnosed and/or asymptomatic atrial fibrillation, monitor recurrent atrial fibrillation and treat life-threatening rhythms in the lower chambers of the heart, according to a Medtronic news release.

The company has other FDA-approved, MR-conditional cardiac rhythm and heart failure devices, including MR-conditional pacemakers, ICDs, insertable cardiac monitors and cardiac resynchronization therapy defibrillators (CRT-D’s).

In February, the FDA  approved Medtronic’s Amplia MRI Quad CRT-D SureScan and the Compia MRI Quad CRT-D SureScan systems, which were the first MRI conditional CRT-Ds to treat patients with heart failure and reduce the risk of sudden cardiac arrest.

The Visia ICDs are approved for MRI scans on any part of the body without restrictions and for MRI scans in 1.5 Tesla machines. The system also includes a battery that lasts up to 11 years, a design that reduces skin pressure by 30 percent and a shock reduction algorithm that’s been shown to deliver a 98 percent inappropriate shock-free rate at one year, according to Medtronic.